Clearance Summary
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder received FDA 510(k) clearance under submission number K150369, sponsored by Somnomed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-06-18.
- Submission: K150369
- Applicant / Sponsor: Somnomed, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2015-06-18
Classification & Regulation
This clearance is catalogued under FDA product code PLC and 21 CFR 872.5570, within the Dental review panel as a Class II device.