FDA 510(k) Applications for Medical Device Product Code "PLC"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K160239 | Airway Management, Inc. | TAP 3, TAP 1 | 08/10/2016 |
| K170606 | Gergen's Orthodontic Lab | Acrylic Herbst Appliance with Micro-Recorder | 11/16/2017 |
| K181571 | Mark Abramson, D.D.S., Inc | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | 04/19/2019 |
| K161624 | MICRODENTAL, Inc. | MicrO2 OSA Device with Micro-Recorder | 11/07/2016 |
| K172859 | Prosomnous Sleep Technologies | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | 11/22/2017 |
| K190353 | Residential Home Sleep Services | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | 04/10/2020 |
| K150369 | SOMNOMED INC. | 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, Somn | 06/18/2015 |
| K233497 | Somnomed, Inc. | Rest Assure System | 10/03/2024 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
