Data / Medical devices / United States / Lynch Biologics LLC
Lynch Biologics LLC: FDA-registered device maker in Franklin, TN, United States, 1 PMA approval
Lynch Biologics LLC is registered with the FDA (registration 3011175224) in Franklin, TN, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated November 18, 2005. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011175224
- Address
- 393 Nichol Mill Ln Ste 280, Franklin, TN, United States, 37067
- Owner or operator
- Lynch Biologics LLC (10058000)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 24, 2018
- Registered through
- 2027
- Brand names listed
- Gem 21S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biologic Material, Dental | NQA | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bone Grafting Material, Dental, With Biologic Component | NPZ | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 18, 2005 | P040013 | GEM 21S (GROWTH-FACTOR ENHANCED MATRIX | NPZ | 29 | August 3, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Dental, With Biologic Component
- All makers of Biologic Material, Dental
Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.