Last synced on 2 December 2022 at 11:04 pm

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) wit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150369
510(k) Type
Traditional
Applicant
SOMNOMED INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/18/2015
Days to Decision
125 days
Submission Type
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) wit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150369
510(k) Type
Traditional
Applicant
SOMNOMED INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/18/2015
Days to Decision
125 days
Submission Type
Summary