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Tera Harz II Br-23A3-1000

by Graphy Inc.

Model BR-23A3-1000

Tera Harz II Br-23A3-1000 is a device classified as Class IIa in the EU and Class II in the US made by Graphy Inc., registered in EUDAMED on 22 May 2026 (Basic UDI-DI B-08800142100659), cleared under FDA 510(k) K233502 on 1 Nov 2023 and listed in FDA GUDID since 9 May 2024 (UDI-DI 08800142100659), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233502

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/MDD EUDAMED NumberB-08800142100659 Basic UDI-DI 08800142100659UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800142100659 UDI-DI Date9 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233502 Date1 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800142100659 registered 22 May 2026 Active
  • FDA 510(k) K233502 decided 1 Nov 2023 Active
  • FDA GUDID UDI-DI 08800142100659 listed 9 May 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233502
  2. Listed FDA GUDID 08800142100659
  3. Registered EUDAMED B-08800142100659

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  • Withdrawn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
Tera Harz EUDAMED
Tera Harz II GUDID
Generic name
Dental prosthesis veneer resin
Model / Ref / Catalog
BR-23A3-1000
Primary DI / UDI-DI
08800142100659
Basic UDI-DI
B-08800142100659
510(k) Number
FDA product code
EBF, EBG
EMDN code
Q0102050199 Dentistry resins - other
GMDN term
Dental prosthesis veneer resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690, 872.3770
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
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 (K233502)

and 8 more cleared under K233502

Similar devices in this category

Other devices filed under DENTISTRY RESINS - OTHER.

Other devices from Graphy Inc.

See all devices from Graphy Inc. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)