Data / Medical devices / United States / Biomat Sciences, Inc.
Biomat Sciences, Inc.: FDA-registered device maker in Bethesda, MD, United States, 1 510(k) clearance
Biomat Sciences, Inc. is registered with the FDA (registration 1125730) in Bethesda, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1125730
- FEI number
- 3002838732
- Address
- 5612 Glenwood Rd, Bethesda, MD, United States, 20817
- Owner or operator
- BIOMAT SCIENCES, INC. (9039008)
- Roles
- Manufacturer
- First device listed
- January 25, 2008
- Registered through
- 2026
- Brand names listed
- Primagen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 1999 | K992838 | ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE | KLE | Substantially Equivalent | Biomat Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 1999. 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.