Manufacturer registered with FDA
Palaxa Precision LLC
Newport, MN, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Palaxa Precision LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | — | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2026 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | — | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Palaxa Precision LLC 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: Craniofacial Technologies, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Apr 2022 | K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | OAT Orthodontic Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PALAXA PRECISION LLCFDA reg. 3043841530 | Newport, MN, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094830). 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.