Manufacturer registered with FDA
Exactech, Inc.
Gainesville, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12011–2011
- Markets registered in
- 9514 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Exactech, 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 | Exactech, Inc. | 1 clearances | 2011–2011 | Below |
| Canada | Health Canada | Registration holder | EXACTECH INC. | 234 | 2005–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Exactech Inc. | 79 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Exactech Inc | 77 | 2009–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EXACTECH, INCEXACTECH INC · EXACTECH, INC. | 43 | 2011–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Exactech, Inc. | 39 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Exactech, Inc.Exactech Inc. · Exactech. Inc. | 18 | 2003–2022 | Pure Global AI |
| Colombia | INVIMA | Registration holder | EXACTECH INC | 17 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EXACTECH INC. | 7 | 1994–2015 | 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 Exactech, 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 |
|---|---|---|---|---|
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | Optecure DentalOptecure Dental +CCC | 2011 |
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 Exactech, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Aug 2011 | K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | NUN Human Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EXACTECH, INC.FDA reg. 1038671 | GAINESVILLE, FL, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1038671). 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.