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SINGLE BONDING 3ml

by Dmp Dental Industry S.A.

Part of a family of 24 devices: see the family page

Ref 130106003

SINGLE BONDING 3ml is a device classified as Class IIa in the EU and Class II in the US made by Dmp Dental Industry S.A., registered in EUDAMED on 18 May 2026 (Basic UDI-DI 5206569COTH52SN) and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 05206569760019), 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 Number5206569COTH52SN Basic UDI-DI 05206569760019UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05206569760019 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5206569COTH52SN registered 18 May 2026 Active
  • FDA GUDID UDI-DI 05206569760019 listed 22 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05206569760019
  2. Registered EUDAMED 5206569COTH52SN

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  • Withdrawn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
Single Bonding 3ml EUDAMED
Single Bonding GUDID
Generic name
Dentine bonding agent/set
Device name
Dental Adhesive
Model / reference
130106003 EUDAMED
3ml GUDID
Primary DI / UDI-DI
05206569760019
Basic UDI-DI
5206569COTH52SN
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
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
130106003
GUDID
3ml
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 Dmp Dental Industry S.A.

See all devices from Dmp Dental Industry S.A. →

Properties

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