Data / Medical devices / United States / Gergens Orthodontic Lab
Gergens Orthodontic Lab: FDA-registered device maker in Phoenix, AZ, United States, 2 510(k) clearances
Gergens Orthodontic Lab is registered with the FDA (registration 3008274496) in Phoenix, AZ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 17, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008274496
- Address
- 1745 West Deer Valley Rd Suite 112, Phoenix, AZ, United States, 85027
- Owner or operator
- Gergens Orthodontic Lab (10031363)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 20, 2010
- Registered through
- 2026
- Brand names listed
- Acylic Herbst, TAP, Vivos DNA Appliance, mRNA Appliance, mmRNA appliance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2013 | K113126 | ACRYLIC HERBST APPLIANCE | LRK | Substantially Equivalent | Gergens Orthodontic Lab | accessdata.fda.gov |
| December 12, 2006 | K062951 | TAP III ANTI-SNORING DEVICE | LRK | Substantially Equivalent | Airway Management, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Wire, Orthodontic
Updated July 17, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.