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Visalys Restorative Primer 13581

by Kettenbach GmbH & Co. KG

Ref 13581Model Visalys Restorative Primer

Visalys Restorative Primer 13581 is a dental prosthesis priming agent (EU MDR Class IIa; FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Kettenbach GmbH & Co. KG, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI ++E217VRPUB) and listed in FDA GUDID since 25 Nov 2019 (UDI-DI E217135811), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E217VRPUB Basic UDI-DI E217135811UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE217135811 UDI-DI Date25 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E217VRPUB registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI E217135811 listed 25 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E217135811
  2. Registered EUDAMED ++E217VRPUB

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  • Withdrawn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
Visalys Restorative Primer
Generic name
Dental prosthesis priming agent
Model / Ref / Catalog
13581, Visalys Restorative Primer
Primary DI / UDI-DI
E217135811
Basic UDI-DI
++E217VRPUB
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dental prosthesis priming agent
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Standard device
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: Dental prosthesis priming agent

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from Kettenbach GmbH & Co. KG

See all devices from Kettenbach GmbH & Co. KG →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)