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Etching Gel 3ml

by Dmp Dental Industry S.A.

Part of a family of 14 devices: see the family page

Ref 130101003

Etching Gel 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 29 Apr 2026 (Basic UDI-DI 5206569COTH51SL) and listed in FDA GUDID since 1 Sep 2017 (UDI-DI 05206569730012), 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 Number5206569COTH51SL Basic UDI-DI 05206569730012UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05206569730012 UDI-DI Date1 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5206569COTH51SL registered 29 Apr 2026 Active
  • FDA GUDID UDI-DI 05206569730012 listed 1 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05206569730012
  2. Registered EUDAMED 5206569COTH51SL

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  • Withdrawn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
Etching Gel 3ml EUDAMED
Etching Gel GUDID
Generic name
Dental tooth-etching solution
Device name
Dental Etchant
Model / reference
130101003 EUDAMED
3ml GUDID
Primary DI / UDI-DI
05206569730012
Basic UDI-DI
5206569COTH51SL
FDA product code
EBF
EMDN code
Q01010402 Enamel-dentinal etching materials
GMDN term
Dental tooth-etching solution
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
130101003
GUDID
3ml
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 etching solution

Similar devices in this category

Other devices filed under ENAMEL-DENTINAL ETCHING MATERIALS.

Other devices from Dmp Dental Industry S.A.

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

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)