Manufacturer registered with FDA
Sigmar Italia S.p.A.
ALME, BERGAMO, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Italy
Devices listed with FDA
What Sigmar Italia S.p.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Antibacterial (by Physical Means) Oral RinseNTO · Class 2 | — | Maker | Decapinol Oral Rinse | 2011 |
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 |
|---|---|---|
| Sigmar Italia S.P.AFDA reg. 3003311293 | ALME Bergamo, Italy | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080151). 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.