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Prime&Bond® XP 693002

by Dentsply International

Ref 693002

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D010ADH03MG Basic UDI-DI D0026930021UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD0026930021 UDI-DI Date27 Jun 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Prime&Bond XP Unit Dose Package EUDAMED
Prime&Bond® XP GUDID
Generic Name
Dentine bonding agent/set
Model / Ref / Catalog
693002
Primary DI / UDI-DI
D0026930021
Basic UDI-DI
++D010ADH03MG
Unit of Use DI
D0026930020
FDA Product Code
KLE
EMDN Code
Q01010104 Dental bonding agents
GMDN Term
Dentine bonding agent/set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3200
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

Related devices

Category: Dentine bonding agent/set

Other devices from Dentsply International

See all devices from Dentsply International →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • CMR Substance
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No