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Peak Universal Bond S4551

by Ultradent Products, Inc.

Ref S4551

Peak Universal Bond S4551 is a device classified as Class III in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0883205-REFS4551H5) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205045928), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-REFS4551H5 Basic UDI-DI 00883205045928UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205045928 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-REFS4551H5 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 00883205045928 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205045928
  2. Registered EUDAMED 0883205-REFS4551H5

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  • Withdrawn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
Peak Universal Bond & Ultra-Etch EUDAMED
Peak Universal Bond GUDID
Generic name
Dentine adhesive
Dentine bonding agent/set
Model / Ref / Catalog
S4551
Primary DI / UDI-DI
00883205045928, 00883205102058
Basic UDI-DI
0883205-REFS4551H5
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine adhesive
Dentine bonding agent/set
Device class
Class III EUDAMED
Class II GUDID
Regulation number
872.3200
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Intended for professional dental use to provide adhesive bonding between tooth structure and direct or indirect dental restorative materials during restorative and prosthetic dental procedures.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Dentine adhesive

Other devices from Ultradent Products, Inc.

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Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)