**[BIBLIOGRAPHY]{.underline}**

**[DENTAL DEVICES BRANCH]{.underline}**

1.  Department of Health and Human Services, Food and Drug
    Administration, 21 CFR Part 872. Docket No. 02N-0010, *Dental
    Devices: Classification for Intraoral Devices for Snoring and/or
    Obstructive Sleep Apnea*. **Proposed Rule**. Federal Register: April
    5, 2002.

2.  Department of Health and Human Services, Food and Drug
    Administration, 21 CFR Part 872. Docket No. 02N-0010, *Dental
    Devices; Classification for Intraoral Devices for Snoring and/or
    Obstructive Sleep Apnea*. **Final Rule**. Federal Register: November
    12, 2002 (Vol 67, No. 218).

3.  **FDA Guidance Document**. *[Class II Special Controls Guidance
    Document: Intraoral Devices for Snoring and/or Obstructive Sleep
    Apnea; Guidance for Industry and FDA.]{.underline}* Issued: November
    12, 2002.

4.  Ferguson K, Oho T, Lowe A, Keenan S, and Fleetham J. *A Randomized
    Crossover Study of an Oral Appliance vs Nasal-Continuous Positive
    Airway Pressure in the Treatment of Mild-Moderate Obstructive Sleep
    Apnea*. CHEST, 109/5/May, 1996 pp 1269-1275.

5.  Menn S, Loube D, Morgan T, Mitler M, Berger J, Erman M. *The
    Mandibular Repositioning Device: Role in the Treatment of
    Obstructive Sleep Apnea*. SLEEP, 19 (10): 794-800, 1996.

6.  Schmidt-Nowara W, Lowe A, Wiegand L, Cartwrigth R, Perez-Guerra F,
    Menn S. *Oral Appliances for the Treatment of Snoring and
    Obstructive Sleep Apnea: A Review*. SLEEP, 18 (6): 501-510, 1995.

7.  Lavie P, Herer P, Peled R, Berger J, Yoffe N, Zomer J, Rubin A.
    *Mortality in Sleep Apnea Patients: A Multivariate Analysis of Risk
    Factors*. SLEEP 18(3): 149-157, 1995.

8.  Bliwise D, Bliwise N, Partinen, M, Pursley A, Dement W. *Sleep Apnea
    and Mortality in an Aged Cohort*. American Journal of Public Health,
    May 1988. Vol 78 No.5.

9.  Fritsch K, Iseli A, Russi E, and Bloch K. *Side Effects of
    Mandibular Advancement Devices for Sleep Apnea Treatment*. Am
    Journal of Crital Care Medicine Vol 164 pp 813-818m 2001.

Page 2 -- Bibliography, Dental Devices Branch

10. Marklund M, Stenlund H, Franklin K. *Mandibular Advancement Devices
    in 630 Men and Women with Obstructive Sleep Apnea and Snoring,
    Tolerability and Predictors of Treatment Success*. CHEST, 2004;
    125:1270-1278.

11. Robertson C, Herbison P, Harkness M. *Dental and Occlusal Changes
    During Mandibular Advancement Splint Therapy in Sleep Disordered
    Patients*. European Journal of Orthodontics 25 (2003),371-376.

12. Rose E, Staats R, Virchow C, Jonas I. *Occlusal and Skeletal Effects
    of an Oral Appliance in the Treatment of Obstructive Sleep Apnea*.
    CHEST / 122 / 3 / Sept, 2002.

13. Clark G, Sohn J, Hong C. *Treating Obstructive Sleep Apnea and
    Snoring: Assessment of an Anterior Mandibular Positioning Device*.
    JADA, Vol. 131, June 2000.

14. Lowe A. *Dental Appliances for the Treatment of Snoring and
    Obstructive Sleep Apnea*, Chapter 69.

15. Robertson C. *Dental and Skeletal Changes Associated with Long-Term
    Mandibular Advancement*. SLEEP, Vol. 24, No 5, 2001.

> 16\. Hoekema A, Stegenga B, deBont LGM, *Efficacy and Co-morbidity of
> Oral*
>
> *Appliances in the Treatment of Obstructive Sleep Apnea-Hypopnea: A
> System*
>
> *Review*. Critical Review of Oral Biological Medicine.15(3)
> 137-155(2004).