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Prelude 91657

by Danville Materials, LLC

Ref 91657

Prelude 91657 is a device classified as Class IIa in the EU and Class II in the US made by Danville Materials, LLC, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 081659402D02434) and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 00816594021716), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081659402D02434 Basic UDI-DI 00816594021716UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816594021716 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081659402D02434 registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 00816594021716 listed 22 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816594021716
  2. Registered EUDAMED 081659402D02434

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  • Withdrawn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
Prelude
Generic name
Dentine bonding agent/set
Device name
Prelude One Adhesive
Model / Ref / Catalog
91657
Primary DI / UDI-DI
00816594021716
Basic UDI-DI
081659402D02434
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
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

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 Danville Materials, LLC

See all devices from Danville Materials, LLC →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)