Skip to content

Copalite Snap Bond 4047

by Temrex Corp.

Copalite Snap Bond 4047 is a Class II device made by Temrex Corp., cleared under FDA 510(k) K915511 on 6 Mar 1992 and listed in FDA GUDID since 20 Feb 2020 (UDI-DI 00850015110313), 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) K915511

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 Number00850015110313 UDI-DI Date20 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK915511 Date6 Mar 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K915511 decided 6 Mar 1992 Active
  • FDA GUDID UDI-DI 00850015110313 listed 20 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K915511
  2. Listed FDA GUDID 00850015110313

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Copalite Snap Bond
Generic name
Ceramic dental inlay adhesive solution
Model / reference
4047
Primary DI / UDI-DI
00850015110313
510(k) Number
FDA product code
KLE
GMDN term
Ceramic dental inlay adhesive solution
Device class
Class II
Regulation number
872.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ceramic dental inlay adhesive solution

Similar devices

Other devices filed under FDA product code KLE (Agent, Tooth Bonding, Resin).

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)