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
FDA 510(k) clearance K150369 · decided 2015-06-18
Clearance details
- K-number
- K150369
- Device name
- 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
- Applicant
- Somnomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-13
- Decision date
- 2015-06-18
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- PLC
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Frisco, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Somnomed
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765) | Prosomnus Sleep Technologies | 2026-04-06 |
| Rest Assure System (K233497) | Somnomed, Inc. | 2024-10-03 |
| Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (K190353) | Residential Home Sleep Services | 2020-04-10 |
| OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (K181571) | Mark Abramson, D.D.S., Inc. | 2019-04-19 |
| Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (K172859) | Prosomnous Sleep Technologies | 2017-11-22 |
| Acrylic Herbst Appliance with Micro-Recorder (K170606) | Gergen'S Orthodontic Lab | 2017-11-16 |
| MicrO2 OSA Device with Micro-Recorder (K161624) | Microdental, Inc. | 2016-11-07 |
| TAP 3, TAP 1 (K160239) | Airway Management, Inc. | 2016-08-10 |
Recalls involving this device
No recalls on record reference this clearance.