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Peak Universal Bond 5006

by Ultradent Products, Inc.

Ref 5006

Peak Universal Bond 5006 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 Jun 2026 (Basic UDI-DI B-00883205035776) and listed in FDA GUDID since 11 Mar 2025 (UDI-DI 00883205035776), 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-00883205035776 Basic UDI-DI 00883205035776UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205035776 UDI-DI Date11 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00883205035776 registered 29 Jun 2026 Active
  • FDA GUDID UDI-DI 00883205035776 listed 11 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205035776
  2. Registered EUDAMED B-00883205035776

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  • Withdrawn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
Peak Universal Bond
Generic name
Dentine bonding agent/set
Model / Ref / Catalog
5006
Primary DI / UDI-DI
00883205035776
Basic UDI-DI
B-00883205035776
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 registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Category: Dentine bonding agent/set

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)