Manufacturer registered with FDA
Lynch Biologics LLC
Franklin, TN, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Lynch Biologics LLC 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 | Lynch Biologics LLC | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Lynch Biologics LLC | 1 | 2023–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | LYNCH BIOLOGICS LLC | 1 | 2021–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Lynch Biologics, LLC | 1 | 2023–2023 | 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 Lynch Biologics LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Bone Grafting Material with Biologic ComponentNPZ · Class 3 | — | Maker | Gem 21S | 2018 |
| Dental Biologic MaterialNQA · Class 3 | — | Maker | Gem 21S | 2018 |
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 |
|---|---|---|
| LYNCH BIOLOGICS LLCFDA reg. 3011175224 | Franklin, TN, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058000). 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.