Manufacturer registered with FDA
SigmaGraft, Inc.
Fullerton, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 32015–2023
- Markets registered in
- 1280 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name SigmaGraft, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SigmaGraft, Inc. | 3 clearances | 2015–2023 | Below |
| Colombia | INVIMA | Registration holder | SIGMAGRAFT, INC.SIGMAGRAFT INC. | 36 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SigmaGraft Inc. | 15 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SigmaGraft, IncSigmaGraft, inc · SigmaGraft Inc. · +2 | 8 | 2013–2022 | Pure Global AI |
| Canada | Health Canada | Registration holder | SIGMAGRAFT INC. | 4 | 2023–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SIGMAGRAFT, INC.SIGMAGRAFT INC · SIGMAGRAFT, INC | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | SigmaGraft Inc | 3 | 2024–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SIGMAGRAFT INC | 3 | 2025–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SigmaGraft, Inc.SigmaGraft Inc. | 3 | 2017–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SigmaGraft, Inc. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SigmaGraft Inc | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Sigma Graft | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What SigmaGraft, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | InterOssInterOss CollagenMaxxeusMaxxeus Dental Xenograft ParticulatesMega-Oss BovineTM | 2015 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | InterCollagen Guide | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names SigmaGraft, Inc. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIGMAGRAFT, INC.FDA reg. 3009598981 | Fullerton, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040723). 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.