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reliaBond Xtra AH1200

by Advanced Healthcare Ltd.

Ref AH1200

reliaBond Xtra AH1200 is a dentine bonding agent/set (EU MDR Class IIa; FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Advanced Healthcare Ltd., registered in EUDAMED on 22 May 2026 (Basic UDI-DI 5056009120107S6) and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 05060446606216), 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 Number5056009120107S6 Basic UDI-DI 05060446606216UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060446606216 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5056009120107S6 registered 22 May 2026 Active
  • FDA GUDID UDI-DI 05060446606216 listed 8 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060446606216
  2. Registered EUDAMED 5056009120107S6

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  • Withdrawn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
reliaBond Light Cured Adhesive 5ml EUDAMED
reliaBond Xtra GUDID
Generic name
Dentine bonding agent/set
Device name
1 Step Bond (self etching) / 1-Part Bonding Agent
Model / reference
AH1200
Primary DI / UDI-DI
05060446606216
Basic UDI-DI
5056009120107S6
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
Standard device
EU market of registration
Malta
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 Advanced Healthcare Ltd.

See all devices from Advanced Healthcare Ltd. →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)