Skip to content

Temrex-Dentin Varnish

by Temrex Corp.

510(k) K851030

Temrex-Dentin Varnish is a Class II device made by Temrex Corp., cleared under FDA 510(k) K851030 on 20 Jun 1985, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851030 Date20 Jun 1985ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LBH
Device class
Class II
Regulation
21 CFR Part 872.3260
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K851030

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K851030
UDI-DISize and differences
COPALITE 4001
Temrex Corp.
400100850015110283 —On the market
COPALITE 4002
Temrex Corp.
400200850015110290 —On the market
COPALITE 4003
Temrex Corp.
400300850015110306 —On the market

Similar devices

Other devices filed under FDA product code LBH (Varnish, Cavity).

Other devices from Temrex Corp.

See all devices from Temrex Corp. →