Manufacturer registered with FDA
Gergens Orthodontic Lab
Phoenix, AZ, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 32013–2017
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Gergens Orthodontic Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Acylic HerbstmmRNA appliancemRNA ApplianceTAP | 2010 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Vivos DNA Appliance | 2019 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | mmRNA appliance | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Gergens Orthodontic Lab as the applicant.
Also lists devices cleared under other names
Gergens Orthodontic Lab lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Airway Management, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Dec 2006 | K062951 | TAP III ANTI-SNORING DEVICE | Airway Management, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GERGENS ORTHODONTIC LABFDA reg. 3008274496 | Phoenix, AZ, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031363). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.