Registered with FDA
GAMMATOM Srl
GUANZATE, Italy. 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
- 1Italy
Devices listed with FDA
What GAMMATOM Srl 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 | Lister | — | 2023 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | — | 2023 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Lister | — | 2023 |
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 |
|---|---|---|
| Gammatom S.r.l.FDA reg. 9681465 | GUANZATE (CO) Como, Italy | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9023536). 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.