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Transcend 4814-

by Ultradent Products, Inc.

Part of a family of 20 devices: see the family page

Ref 4814

Transcend 4814- is a device classified as Class IIa in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 29 May 2026 (Basic UDI-DI 0883205-TF271TransHJ), cleared under FDA 510(k) K201795 on 28 Sep 2020 and listed in FDA GUDID since 28 Sep 2021 (UDI-DI 00883205028433), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201795

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF271TransHJ Basic UDI-DI 00883205028433UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205028433 UDI-DI Date28 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK201795 Date28 Sep 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF271TransHJ registered 29 May 2026 Active
  • FDA 510(k) K201795 decided 28 Sep 2020 Active
  • FDA GUDID UDI-DI 00883205028433 listed 28 Sep 2021 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3068-2024 FDA Class II initiated 2 Aug 2024
    • Ongoing Z-3067-2024 FDA Class II initiated 2 Aug 2024

    Due to a manufacturing issue, red particulates present in the expressed composite.

Timeline

5 dated events

  1. Cleared FDA 510(k) K201795
  2. Listed FDA GUDID 00883205028433
  3. Recall initiated FDA recalls Z-3068-2024
  4. Recall initiated FDA recalls Z-3067-2024
  5. Registered EUDAMED 0883205-TF271TransHJ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Transcend
Generic name
Dental composite resin
Model / Ref / Catalog
4814 EUDAMED
4814- GUDID
Primary DI / UDI-DI
00883205028433
Basic UDI-DI
0883205-TF271TransHJ
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4814
GUDID
4814-
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa 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

Cleared under the same submission (K201795)

and 8 more cleared under K201795

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)