510(k) K170606
- Device
- Acrylic Herbst Appliance With Micro-Recorder
- Applicant
- Gergen's Orthodontic Lab
- 510(k) number
- K170606
- Product code
- PLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-16
- Date received
- 2017-03-01
- Regulation
- 872.5570
- Classification name
- Sleep Appliances With Patient Monitoring
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chris Morrison
- Address
- 1745 W. Deer Valley Rd., Suite 112 Phoenix AZ US 85027 85027
FDA Registration Numbers#
- 3008186372
- 3005598536
- 3013116677
- 3013950969
- 3009440973
- 3010022489
- 3015674959
- 3002912391
- 1937100
- 3004748290
- 3005343849
Source Documents#
Other 510(k) Records For Product Code PLC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026-04-06 |
| K233497 | Rest Assure System | Somnomed, Inc. | 2024-10-03 |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020-04-10 |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | 2019-04-19 |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | 2017-11-22 |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016-11-07 |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | 2016-08-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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