Manufacturer registered with FDA
Eptam West LLC
Colorado Springs, CO, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Eptam West 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 |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | JEY - PLATE, BONE | 2017 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | OAT - Implant, endosseous, orthodontic | 2017 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | DZL - SCREW, FIXATION, INTRAOSSEOUS | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EPTAM WEST LLCFDA reg. 3011302692 | Colorado Springs, CO, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048254). 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.