K150369 is an FDA 510(k) clearance for the 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. This device is classified as a Sleep Appliances With Patient Monitoring (Class II - Special Controls, product code PLC).
Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on June 18, 2015, 125 days after receiving the submission on February 13, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570. For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy..
| 510(k) Number | K150369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2015 |
| Decision Date | June 18, 2015 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLC - Sleep Appliances With Patient Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy. |