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Prime-Crown A1

by Prime Dental

Ref 100-103A1

Prime-Crown A1 is a temporary dental crown/bridge resin (EU MDD Class IIa; FDA Class I; FDA product code ELZ, Crown, Preformed) made by Prime Dental, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI B-00817441022269) and listed in FDA GUDID since 6 Nov 2019 (UDI-DI 00817441022269), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817441022269 Basic UDI-DI 00817441022269UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817441022269 UDI-DI Date6 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00817441022269 registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 00817441022269 listed 6 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817441022269
  2. Registered EUDAMED B-00817441022269

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Prime-Crown
Generic name
Temporary dental crown/bridge resin
Model / reference
100-103A1 EUDAMED
A1 GUDID
Primary DI / UDI-DI
00817441022269
Basic UDI-DI
B-00817441022269
FDA product code
ELZ
EMDN code
Q0102050101 Temporary teeth resins
GMDN term
Temporary dental crown/bridge resin
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3330
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
Model / referenceEUDAMED
100-103A1
GUDID
A1
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Temporary dental crown/bridge resin

Similar devices in this category

Other devices filed under TEMPORARY TEETH RESINS.

Other devices from Prime Dental

See all devices from Prime Dental →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)