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Tne 7700

by Temrex Corp.

Ref 7700

Tne 7700 is a device classified as Class I in the EU and Class II in the US made by Temrex Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00850015110061), cleared under FDA 510(k) K884081 on 2 Dec 1988 and listed in FDA GUDID since 14 Jan 2020 (UDI-DI 00850015110061), 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) K884081

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-00850015110061 Basic UDI-DI 00850015110061UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850015110061 UDI-DI Date14 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK884081 Date2 Dec 1988DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00850015110061 registered 27 Oct 2026 Active
  • FDA 510(k) K884081 decided 2 Dec 1988 Active
  • FDA GUDID UDI-DI 00850015110061 listed 14 Jan 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) K884081
  2. Listed FDA GUDID 00850015110061
  3. Registered EUDAMED B-00850015110061

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  • Withdrawn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 TNE EUDAMED
Tne GUDID
Generic name
Dental acrylic resin
Model / reference
7700
Primary DI / UDI-DI
00850015110061
Basic UDI-DI
B-00850015110061
510(k) Number
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
GMDN term
Dental acrylic resin
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental acrylic resin

Cleared under the same submission (K884081)

and 8 more cleared under K884081

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

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)