EN KRENINSTRUCTIONSIMPORTANT :READ ALL INSTRUCTIONS THOROUGHLY BEFORE USE.
KEEP THIS LEAFLET AND REFER TO IT PERIODICALLY.

Dental Adhesive Resin for Filling
Polymer-based Pit and Fissure Sealant, Class 1

Bondfill SB

FOR DENTIST USE ONLY

1. What is Bondfill SB?
Bondfill SB is a self-cure, self-adhesive resin for dental restorations. It contains
4-META/MMA-TBB. Though it requires no bonding agent, Bondfill SB forms strong
bonds to enamel, dentin, and restorative materials without gapping and discoloration.
It is also designed to absorb intense, complicated complex external stresses andgreatly resist wear. The Powder contains PMMA and TMPT reactive organic filler
which creates a tough restoration that is hard yet still very resilient. The inorganic
filler loading is 1.2 vol% (as powder) with a particle size range of 5 to 50 nm.
Typical Applications:
Bondfill SB is indicated wherever resilience is required, such as:a. Restoration of tooth wear, such as attrition, abrasion, abfraction, wedge-shaped defects
b. Secondary caries at a restoration marginc. Repair of fractured prostheses and damaged restorations
d. Sealing incipient pit and fissure caries
Note: Bondfill SB is not indicated to use for the restoration of occlusal surface.

2. Contents of the kit

2.1 Bondfill SB Kit:
Base ------------------------------------------------------------------------ 1 (8mL)
Catalyst V--------------------------------------------------------------- 1 (0.7mL)
Powder Cervical (approx. Shade A4) -------------------------------- 1 (3g)
Powder Medium (approx. Shade A3.5)------------------------------- 1 (3g)Teeth Primer -------------------------------------------------------------- 1 (3mL)
Sponge (L • S) --------------------------------------------------------------------- 1
Dispensing Stand --------------------------------------------------------------- 1
Dispensing Cups---------------------------------------------------------------- 20
Brush Handle (Bent) ------------------------------------------------------------ 1
Brush Tips (Brush-dip L) Label color: Pink ------------------------------- 10
Brush Tips (Brush-dip LL) Label color: Purple -------------------------- 10
Attached documents : Instructions / Pictorial Instruction Card

2.2 Refills:• Base ------------------------------------------------------------------------------- 8mL• Catalyst V ----------------------------------------------------------------------0.7mL• Powder Light (approx. Shade A2) ------------------------------------------- 3g• Powder Medium (approx. Shade A3.5)------------------------------------- 3g• Powder Cervical (approx. Shade A4) --------------------------------------- 3g• Powder Opacious (approx. Shade A3 Opaque)-------------------------- 3g• Teeth Primer--------------------------------------------------------------------- 3mL• Sponge (L • S) ----------------------------------------------------------------------- 1• Dispensing Stand ------------------------------------------------------------------ 1• Dispensing Cups ----------------------------------------------------------------- 40• Brush Handle (Straight) ---------------------------------------------------------- 1• Brush Handle (Bent) -------------------------------------------------------------- 1• Brush Tips (Brush-dip S) Label color: Green ----------------------------- 10• Brush Tips (Brush-dip L) Label color: Pink -------------------------------- 10• Brush Tips (Brush-dip LL) Label color: Purple---------------------------- 10

3. Precautions : Read all instructions thoroughly before use.
3.1 Safety
Sensitivity
Bondfill SB should not be used by clinicians or on patients who are sensitive tomethacrylates or acetone. If signs of irritation such as redness appear, stopusing Bondfill SB immediately and consult a physician.
Avoid contact
Avoid contacting soft tissues, skin or eyes by Bondfill SB components. The useof rubber dam is recommended. Contaminated skin or mucosa should bewiped immediately with alcohol and then rinsed thoroughly with copious
amounts of running water. If Bondfill SB components enter the eye, rinse
immediately and thoroughly with running water and have the patient examinedby an ophthalmologist. Clinicians should use dental gloves.
Flammability
Catalyst V, Base, and Teeth Primer are flammable. Do not store where they
may be exposed to open flame.
Applications
Use Bondfill SB only for the applications recommended in these instructions.

3.2 Precautions on Catalyst VCatalyst V reacts with air and water to generate heat and lose activity.
Please abide by the following.
Storage conditions
Avoid high temperature, high humidity and direct sunlight. The repeatedtemperature changes may cause the syringe to aspirate air, thereby shortening
the Catalyst V's shelf-life.
*After prolonged storage, the first drop of the Catalyst V may be inactive due toexposure to air, though the rest of the material remains active. Express anddispose of a drop before making the mix.
*The syringe is made of glass, therefore it must be handled with care to prevent
shock, dropping, and other physical damage.
Cap closure
The cap simply slides on and off. Recap the syringe immediately after eachuse. Air (oxygen and humidity) deactivates the Catalyst V. Do not leave thecap off during the bonding procedure.
Expressing the CatalystIf the Catalyst V does not come out of the syringe because the tip is blocked or
the screw is tight, do not try too hard to turn it. The contents may splash as thesyringe breaks.
After use
Unscrew the syringe screw two turns counter-clockwise after each use torelieve pressure on the Catalyst. (Pressure buildup can cause leakage of theCatalyst V or even crack the syringe.)
Clean spilled Catalyst V immediately with wet towels
The Catalyst V reacts with oxygen. If absorbed by a flammable material, it may
raise the temperature enough to cause smoldering. If the Catalyst V is spilled,wipe it up immediately with a WET (not dry) disposable towel. Then rinse thetowel to deactivate the Catalyst V thoroughly in running water.
Cleaning syringe
Wipe the tip of the syringe with a dry gauze after each use to prevent residuebuildup. Then rinse the gauze with water to kill any remaining activity. Buildupof the residue may prevent the cap from seating properly.
3.3 Storage
Please take the following precautions to maintain the quality.

Storage conditions
Store Catalyst V, Base and Teeth Primer in a cool and dark location. Hightemperature, high humidity and direct sunlight will shorten their shelf-life.
Volatility
Teeth Primer and Base are highly volatile. Recap the bottle immediately.
Contamination
To avoid contamination, do not mix the components with other materials.
Firmly recap the containers immediately after use. Dispose of any excess of
mixed materials after use. Once dispensed do not return materials to thecontainers. Both Dispensing Cups and Brush Tips are for one-time use.
Dispose of them after use.

As in any dental treatment, the patient's individual constitution and the uniquerequirements of clinical case at hand must be considered before selecting
materials and conditions for use.
4. How to use Bondfill SB
a. Surface preparation
1) Cleaning
Remove contaminants and stains using a polishing bur or oil-free, fluoride-freepumice to expose fresh tooth surface. Rinse thoroughly and dry. A rubber
dam is highly recommended to reduce the chance of contamination by saliva,
breath humidity or blood.

2) Priming
Dispense Teeth Primer into one of the small recesses on the DispensingStand. Using a pledget, keep the surface to be bonded saturated with acopious amount of Teeth Primer for approximately 20 seconds. Care should
be taken not to contact the gingiva with the pledget. Then air dry. Rinsing is
not needed.
Standard application time
SurfaceEnamel
DentinTeeth PrimerApprox. 20 sec

After application Dry without rinsing

Enamel Etchant Gel Dentin Etchant Gel
30 sec-30-60 sec
5-10 sec

Rinse and dry*If the surface is cut enamel, use either Teeth Primer or Enamel Etchant Gel. Ifthe surface is uncut enamel, however, Enamel Etchant Gel is recommended.
If the surface is dentin, use either Teeth Primer or Dentin Etchant Gel.
*Both Enamel Etchant Gel and Dentin Etchant Gel are sold separately by Sun
Medical Co., Ltd. Unlike the Teeth Primer (which should not be rinsed from thetooth surface), Enamel Etchant Gel and Dentin Etchant Gel must be rinsed off
the proper etching period (see table above).
*If a precious metal or ceramic restoration is present on the tooth surface tobe treated, prime the metal or ceramic surface after priming the tooth surface
with Teeth Primer.

3) Metal Surface
Rinse the metal surface thoroughly and dry. Applying the Enamel Etchant Gelhelps remove surface contaminants. Air-abrade the metal surface with50-micron aluminum oxide. If the surface is precious metal, apply a metal primer
such as V-PRIMER on the metal surface to be bonded in order to increase bondstrength and durability. V-PRIMER is sold separately by Sun Medical Co., Ltd.
For application details refer to the instructions for the metal primer.

4) Ceramic (porcelain and zirconia) surface
Depending on the case at hand, clean the porcelain/zirconia surface withabrasive wheels and points or a prophy cup with fluoride-free, oil-free pumice.
Rinse thoroughly with water and dry. Applying the Enamel Etchant Gel helps

remove surface contaminants. An ultrasonic cleaner is also effective. Then,
apply a porcelain primer such as Porcelain Liner M on the porcelain/zirconia
surface to be bonded in order to increase bond strength and durability.
Porcelain Liner M is sold separately by Sun Medical Co., Ltd. For application
details refer to the instructions for the porcelain primer.

b. Preparation of Bondfill SB
Place two Dispensing Cups into two of the three holes in the Dispensing Stand.
Dispense 2-3 drops of the Base into one of the Dispensing Cups. Hold theCatalyst V syringe vertical, and turn the screw to dispense a drop into the Base.
Stir lightly with a brush. This mixture is called "activated liquid." The activatedliquid gradually deactivates. Use it within 3 minutes after preparation.
Activated Liquid
Intended Use

Restoration and Build-up
Pit and Fissure SealantBase

2-3 drops
2 dropsCatalyst VOperartion time

1 drop3 minutes after mixing

c. Restoration/Build-up/Pit and Fissure Sealant
1) Dispense the appropriate amount of Powder into the other Dispensing Cup.
2) Wet the surface to be bonded with the activated liquid.
3) Soak the brush with ample activated liquid, then dip the brush into the Powder
to form a ball of powder on the tip. Brush the powder ball onto the pre-wet
surface to be bonded.
4) Repeat the procedure until the restoration or the build-up is completed. Whenyou repeat the procedure, clean the brush tip with gauze before you dip it again.
d. Setting and finishing
Wait approximately 10 minutes before finish and polish. If complete setting isdesirable, wait to polish until the next day.
Working time and Setting time of SealantItemSpecification

Setting time

≥40 seconds

Working time

≤5 minutes

StandardISO6874(2005)
ISO6874(2005)

활성화액비율

3.2 Catalyst V사용상의 주의Catalyst V는 공기나 물에 닿으면 발열 분해되고 활성이 저하된다.
성능을 유지하기 위해 아래의 주의사항을 지킬 것.
저장·보관방법다습, 직사광선, 화기를 피해 실온 (1℃-30℃) 에서 보관할 것.
＊장기간 사용하지 않았던 경우, 남은 Catalyst는 활성을 유지하고 있으나처음 한 방울은 활성이 저하되어 있을 수 있다.
＊Catalyst 용기는 Glass제 이다. 충격·낙하 등으로 인해 파손될 우려가있으므로 취급에 주의할 것.
CAP의 개폐CAP은 슬라이드 형태이다. TIP 앞부분의 공기접촉을 피하기 위해 CAP은사용직전에 개봉하고, 사용 후 즉시 밀폐할 것. CAP을 열어둔 채 두지 말 것.
압출 시 주의나사를 돌려 Catalyst V를 적하 할 때, 나사가 뻑뻑하여 액이 용기의 선단에서 나오지않을 때에는 무리하게 나사를 돌리지 말 것. 용기가 파손되어 액이 튈 수 있다.
사용 후의 처리사용 후, 나사를 2회 반대로 돌려서 내압이 생기지 않도록 할 것. 내압이상승하면 액이 새거나 용기가 파손될 우려가 있다.
흘러내린 Catalyst V의 처치Catalyst V는 산소와 반응한다. 마른 종이, 티슈페이퍼, 거즈, 탈지면, 스폰지등 불에 타기 쉬운 물건과 접촉하면 발화될 우려가 있다. 실수로 흘린 경우나액이 샌 경우는 티슈페이퍼, 거즈, 탈지면 등을 반드시 물에 적셔서 닦아 낼 것.
마른 티슈페이퍼 등으로 닦아내거나 그대로 방치하면 발화할 우려가 있다.
의류 등에 묻은 경우에는 즉시 세척할 것.
CAP과 침부분의 청소CAP과 침부분에 하얀가루가 묻어있는 경우가 있다. 부착물은 CAP의밀폐성을 저해하기 때문에 마른 거즈 등으로 닦아 낼 것. 사용 한 거즈는수세할 것.

사용목적Base충전과 수복2-3방울

Pit and Fissure Sealant2방울Catalyst V활성화액의 사용가능시간1방울조제 후 3분이내c. 충전/축성／Pit and Fissure Sealant
1) Dispensing Cup에 소정의 분재를 채취한다.
2) Disposable Tip으로 조제한 활성화액을 피착면에 한층 도포한다.
3) Disposable Tip에 활성화액을 스며들게해 그 붓 끝을 분재에 묻혀 레진볼을만들어 피착면에 올려 축성한다.
4) 목적한 형태가 될 때까지 조작을 반복한다. 반복하기 전에는 Brush Tip을닦으면서 조작을 한다.
d. 완성레진 경화 후 통법에 따라서 형태수정·연마를 한다. (완성시간 : 약10분) 레진의완전경화를 기다린 경우는 익일 이후의 연마조작을 권장한다.
sealant의 작업시간과 셋팅시간제품명사양규격작업시간5분 이상ISO6874(2005)

셋팅시간40초 이하ISO6874(2005)

3.3 보관품질을 유지하기 위해서 아래의 주의사항을 지켜주십시오.
저장·보관방법고온, 다습, 직사광선을 피해 실온(1℃-30℃)에서 보관할 것.
휘발성Teeth Primer와 Base는 휘발성이 높다. 사용 후에는 곧바로 CAP을 닫을 것.
오염오염을 피하기 위해 다른 제품과 혼합해 사용하지 말 것. 사용 후에는 곧바로밀폐할 것. 사용 후의 잔존물은 파기 할 것. 한번 사용한 내용물은 용기에 다시넣지 말 것. Dispensing Cups와 Brush Tip은 일회용이므로 사용 후 파기 할 것.

사용에 있어서는 환자의 개인차도 고려해 증례에 적합한지 판단하여 사용할 것.

4. Bondfill SB의 사용방법a. 표면처리1) CLEANING통법대로 치면 청소를 하고 수세·건조한다. 타액, 습기, 혈액 등과의 오염을피하기 위해 러버댐의 사용을 추천한다.
2) PRIMING
Teeth Primer를 Dispensing Dish 등에 채취하고 스폰지로 잇몸에 묻지않도록 주의하면서 피착면에 도포한다. 도포하고 나서 20초간 젖은 상태를유지시킨 채 놓아둔 후, Air로 충분히 건조시킨다. 세척은 필요하지 않다.
표준처리시간Surface에나멜질상아질도포 후 처리

Teeth PrimerApprox. 20 초건조 (세척불필요)Enamel Etchant Gel Dentin Etchant Gel30초
-30-60 초
5-10 초세척 및 건조*에나멜질의 경우, Teeth Primer 또는 Enamel Etchant Gel 등으로 치면처리를 한다. 단, 미삭제 에나멜질의 경우, Enamel Etchant Gel 등의 적용을권장한다.
*상아질의 경우, Teeth Primer 또는 Dentin Etchant Gel 등으로 치면 처리를한다.
*Enamel Etchant Gel과 Dentin Etchant Gel은 Sun Medical Co., Ltd.에서별도 판매하고 있다.
이 제품들은 Teeth Primer와 달리 표면처리후(표준처리시간을 참조) 수세가 필요하다.
*금속이나 세라믹, 치질이 혼재할 경우에는 연마 등에 따라 각 피착면의깨끗한 면이 나오게 한 후, 처음에 Teeth Primer로 치면 처리를 한다. 그 후,금속면에 귀금속용 Primer(예를 들면 V-PRIMER)를, 세라믹면에는Porcelain Primer(예를 들면 Porcelain Liner M)를 각각 도포한다.
3) 금속면금속의 표면을 수세·건조한다. 금속면의 표면처리를 하기 전에 금속면의세척을 목적으로Enamel Etchant Gel를 적용하고 수세 건조하는 것을권장한다. 비귀금속인 경우는, 피착면에 Alumina Sandblast 처리를 한다.
귀금속인 경우는, 피착면에Alumina Sandblast 처리를 한다. 수세·건조 한피착면에 귀금속용 Primer(예를 들면V-PRIEMR)를 도포한다. V-PRIMER
는 Sun Medical Co., Ltd.에서 별도 판매하고 있다. 사용에 있어서는 재료의첨부문서에 따라주십시오.
4) 세라믹 (도재, 지르코니아)면 및 레진면
도재·지르코니아인 경우는 필요에 따라서 피착면 Alumina Sandblast 처리등을 하고, 수세·건조한다. 도재면의 표면처리를 행하기 전에 도재면의청소를 목적으로 Enamel Etchant Gel을 적용해 수세 건조하는 것을권장한다. 초음파세척기 등의 사용도 가능하다. 그 후, Porcelain
Primer(예를 들면 Porcelain Liner M)를 도포하고 가볍게 Air Blow 한다.
Porcelain Liner M은 Sun Medical Co., Ltd.에서 별도 판매하고 있다.
사용에 있어서는 재료의 첨부문서에 따라주십시오.
b. Bondfill SB 활성화액의 조제
Dispensing Stand (3홀)에 2개의 Dispensing Cup을 세팅한다. 한쪽에Bondfill SB의 액재 2~3방울에 Catalyst V 1방울의 비율로 채취하여활성화액을 만든다. 활성확액은 공기와 반응하여 천천히 활성이 저하되기때문에 조제 후 3분 이내에 사용해주십시오.

Date of issue: 2017-09-05

J072E/1B