Biocompatible PolyJet
Materials
Rapidly produce medical and dental models and devices
Stratasys Biocompatible PolyJet materials support a full range of advanced medical and dental applications, for example:

Dental applications:

Medical applications:•

Accurate and repeatable Dental models•

Biocompatible anatomical models, prototypes and end use parts•

Try-ins models•

Drilling guides•

Patient-specific models for sizing and molds•

Direct printing of indirect bonding trays•

Surgical guides* for more accurate cuts for orthopedic procedures•Soft gingival masks for implantology cases•Biocompatible jigs, and fixtures* with approved 3rd party 510k cleared segmentation software.

Compatible printers (on the main platforms)
Medical platforms (DigitalAnatomy Printer and J5MediJet)

Dental platforms (J5DentaJetand J720)

MED610V

MED615RGDv

N/a

N/aV

MED DABS
MED620
MED625FLX* The approved printing methods per printer can be found in the biocompatibility requirement document per material* Supported Legacy Printer list can be found in the biocompatibility requirement document per material

Spec SheetMaterials biocompatibility matrix•The evaluation has been performed according to biological testing under the procedures and provisions of EN ISO 10993-1:2018 “BiologicalEvaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process” and FDA Guidance “Use of International
Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process”, dated 16June 2016.

•The evaluation tests address the following tests:•cytotoxicity, genotoxicity, delayed hypersensitivity, and USP plastic Class VI that includes tests for irritation, acute systemic toxicity, andimplantation.

•All the Materials are manufactured in an ISO 13485 certified facility.

•Biological evaluation report (BER) will be provided upon request.

2MED610

Categories

Surface Device

Contact

Description

transparent
rigid material

MED615RGD
Opaque rigidmaterial

MED- DABS
Improvedmechanicalproperties rigidmaterial

Devices that contact intact
skin surfaces only.

Mucous membrane

Devices communicating with
intact mucosal membranes.

(< 24 hours

Devices that contact breachedor otherwise compromised
external body surfaces.

(< 24 hours)

compromised surfaces

A2 shade rigidmaterial

MED625FLX
flexible,transparent
material

PermanentSkin

Breached or

VeroGlaze
MED620(> 30 days)
LimitedLimitedExternal

External
Communicating
DeviceCommunicating

Devices that contact the blood
path at one point and serve
as a conduit for entry into thevascular system.

Limited(< 24 hours)

DeviceTissue/bone/dentin

communicating

Devices communicating withtissue, bone, and pulp/dentin
system.

Approved sterilization process

Limited(< 24 hours)
Steam

Steam

Steam

Steam

Steam

Gamma

Gamma

Gamma

Gamma

Gamma

EtO

EtO

EtO

MED610 also evaluated for a component in external communicating gas pathway devices, according to EN ISO 18562-1:2017 “Biocompatibility
evaluation of breathing gas pathways in healthcare applications” - Part 1: Evaluation and testing within a risk management process.
For more information regarding Biocompatibility requirements, Approved sterilization processes, Safety Guidelines and datasheets, please visit oursupport center webpage or contact us.

•Download the Data Sheet Download the Safety Data Sheet•

Images•Use cases

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ISO 9001:2023 Certified© 2023 Stratasys. All rights reserved. Stratasys, the Stratasys Signet logo, Polyjet, FDM, Digital Anatomy Printer, J5 MediJet, J5 DentaJet ,J720
MED610 (Bio-compatible material), MED625FLX™, CL (Flexible biocompatible material) MED615RGD™, IV (Rigid biocompatible material),MED
DABS+TM, IV (Digital ABS™ biocompatible material) and Fortus are registered trademarks of Stratasys Inc. All other trademarks are theproperty of their respective owners, and Stratasys assumes no responsibility with regard to the selection, performance, or use of these nonStratasys products. Product specifications subject to change without notice. PSS_ Biocompatible PolyJet materials