Manufacturer registered with FDA
Cook Biotech Incorporated
West Lafayette, IN, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 32002–2017
- Markets registered in
- 539 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Cook Biotech Incorporated 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 | Cook Biotech Incorporated | 3 clearances | 2002–2017 | Below |
| Taiwan | TFDA | Manufacturer | COOK BIOTECH INCORPORATED | 18 | 2005–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | COOK BIOTECH INCORPORATEDCOOK BIOTECH, INC | 16 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Cook Biotech IncorporatedCook Biotech Inc · Cook Biotech Inc. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | COOK BIOTECH INCORPORATED | 1 | 2019–2019 | 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 Cook Biotech Incorporated 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 Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | DynaMatrixDynaMatrix PlusDynaMatrix Plus Extracellular Membrane | 2008 |
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 Cook Biotech Incorporated as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COOK BIOTECH, INC.FDA reg. 1835959 | West Lafayette, IN, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9031415). 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.