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Copalite 4003

by Temrex Corp.

Copalite 4003 is a Class II device made by Temrex Corp., cleared under FDA 510(k) K851030 on 20 Jun 1985 and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 00850015110306), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K851030

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850015110306 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK851030 Date20 Jun 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K851030 decided 20 Jun 1985 Active
  • FDA GUDID UDI-DI 00850015110306 listed 24 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K851030
  2. Listed FDA GUDID 00850015110306

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Copalite
Generic name
Dental restorative material varnish
Model / reference
4003
Primary DI / UDI-DI
00850015110306
510(k) Number
FDA product code
LBH
GMDN term
Dental restorative material varnish
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental restorative material varnish

Cleared under the same submission (K851030)

Similar devices

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

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)