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Tera Harz Tc-80DPA1

by Graphy Inc.

Model TC-80 Series, BR-23 Series

Tera Harz Tc-80DPA1 is a device classified as Class IIa in the EU and Class II in the US made by Graphy Inc., registered in EUDAMED on 13 Jun 2024 (Basic UDI-DI 88001421TERAHARZVJ), cleared under FDA 510(k) K202846 on 15 Jul 2021 and listed in FDA GUDID since 9 May 2024 (UDI-DI 08800142100109), active as of 23 Oct 2026.

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

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202846

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 Number88001421TERAHARZVJ Basic UDI-DI 08800142100109UDI-DIDate13 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800142100109 UDI-DI Date9 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK202846 Date15 Jul 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88001421TERAHARZVJ registered 13 Jun 2024 Active
  • FDA 510(k) K202846 decided 15 Jul 2021 Active
  • FDA GUDID UDI-DI 08800142100109 listed 9 May 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202846
  2. Listed FDA GUDID 08800142100109
  3. Registered EUDAMED 88001421TERAHARZVJ

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  • Withdrawn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
Tera Harz
Generic name
Dental prosthesis veneer resin
Device name
TERA HARZ, Tera Harz
Model / Ref / Catalog
TC-80 Series EUDAMED
BR-23 Series EUDAMED
TC-80DPA1 GUDID
Primary DI / UDI-DI
08800142100109
Basic UDI-DI
88001421TERAHARZVJ
Direct marketing DI
08800142100109
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
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TC-80 Series, BR-23 Series
none
GUDID
TC-80DPA1
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 (K202846)

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 (20, all answered No)