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— 510(k) K150369

Name: FDA 510(k) clearance K150369
Creator: U.S. Food and Drug Administration
Published: 2015-06-18

Substantially Equivalent

Somnomed, Inc.

FDA 510(k) clearance K150369 for 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, Substantially Equivalent on 2015-06-18. Applicant: Somnomed, Inc.. Device class: 2.

Clearance details

Applicant: Somnomed, Inc.
Product code: Code PLC
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2015-02-13
Decision date: 2015-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.