FDA Product Code
FDA Product Code PLC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5570
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254304 | iNOS intraoral biosensor | Achaemenid, LLC | 2026-08-25 | Traditional | PDF ↗ |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026-04-06 | Traditional | PDF ↗ |
| K233497 | Rest Assure System | Somnomed, Inc. | 2024-10-03 | Traditional | PDF ↗ |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020-04-10 | Traditional | PDF ↗ |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | 2019-04-19 | Traditional | PDF ↗ |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | 2017-11-22 | Traditional | PDF ↗ |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | 2017-11-16 | Traditional | PDF ↗ |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016-11-07 | Traditional | PDF ↗ |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | 2016-08-10 | Traditional | PDF ↗ |
| K150369 | 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 | Somnomed, Inc. | 2015-06-18 | Traditional | PDF ↗ |
Product code PLC · Class II · Dental. Data: openFDA.