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Microetcher 201935-00

by Danville Materials, LLC

Ref 201935-00

Microetcher 201935-00 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 8 Jul 2026 (Basic UDI-DI 081659402D01533) and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 00816594021549), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081659402D01533 Basic UDI-DI 00816594021549UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816594021549 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081659402D01533 registered 8 Jul 2026 Active
  • FDA GUDID UDI-DI 00816594021549 listed 22 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816594021549
  2. Registered EUDAMED 081659402D01533

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  • Withdrawn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
Microetcher
Generic name
Chairside dental abrasive air jet system
Device name
Me - Cd Microetcher
Model / Ref / Catalog
201935-00
Primary DI / UDI-DI
00816594021549
Basic UDI-DI
081659402D01533
Direct marketing DI
00816594021549
FDA product code
KOJ
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Chairside dental abrasive air jet system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6080
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 abrasive air jet system

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Danville Materials, LLC

See all devices from Danville Materials, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)