Manufacturer registered with FDA

Biomat Sciences, Inc.

Bethesda, MD, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9039008Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
11999–1999
Markets registered in
1United States
Establishments
1United States
1999: 11990200020102020

510(k) clearances per year, 1990–2026

Devices listed with FDA

What Biomat Sciences, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
Primagen
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 Biomat Sciences, Inc. as the applicant.

Decided510(k)DeviceDevice type
15 Nov 1999K992838ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATEKLE Resin Tooth Bonding Agent

Registered establishments

EstablishmentLocationWhat it does
BIOMAT SCIENCES, INC.FDA reg. 1125730BETHESDA, MD, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9039008). 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.