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Temrex Diamond Polishing Paste 6800

by Temrex Corp.

Ref 6800

Temrex Diamond Polishing Paste 6800 is a Class I device made by Temrex Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00850015110481), cleared under FDA 510(k) K873686 on 12 Nov 1987 and listed in FDA GUDID since 22 Oct 2020 (UDI-DI 00850015110481), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K873686

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850015110481 Basic UDI-DI 00850015110481UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850015110481 UDI-DI Date22 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK873686 Date12 Nov 1987DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00850015110481 registered 27 Oct 2026 Active
  • FDA 510(k) K873686 decided 12 Nov 1987 Active
  • FDA GUDID UDI-DI 00850015110481 listed 22 Oct 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K873686
  2. Listed FDA GUDID 00850015110481
  3. Registered EUDAMED B-00850015110481

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Temrex EUDAMED
Temrex Diamond Polishing Paste GUDID
Generic name
Dentifrice
Device name
Diamond Polishng Paste
Model / reference
6800
Primary DI / UDI-DI
00850015110481
Basic UDI-DI
B-00850015110481
510(k) Number
FDA product code
EJR
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dentifrice
Device class
Class I
Regulation number
872.6030
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dentifrice

Cleared under the same submission (K873686)

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)