Manufacturer registered with FDA
Criteria Industria e Comercio de Produtos Medicinais e Odont
São Carlos, Brazil. Lists 1 dental device type with FDA across 0 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 0—
Devices listed with FDA
What Criteria Industria e Comercio de Produtos Medicinais e Odont currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | Lumina-PTFE Titanium | 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
Criteria Industria e Comercio de Produtos Medicinais e Odont 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: Criteria Industria E Comercio DE Produtos Medicinais (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Dec 2023 | K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | NPK Intraoral Synthetic Barrier |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096651). 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.