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Tools TDCSt-2.2, 8

by A.B. Dental Devices Ltd

Part of a family of 58 devices: see the family page

Ref TDCSt-2.2,8

Tools TDCSt-2.2, 8 (TDCSt-2.2,8) is a device classified as Class IIa in the EU and Class I in the US made by A.B. Dental Devices Ltd, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 72911127StepDrillsST) and listed in FDA GUDID since 7 Oct 2019 (UDI-DI 07290107275712), 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 Number72911127StepDrillsST Basic UDI-DI 07290107275712UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290107275712 UDI-DI Date7 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 72911127StepDrillsST registered 13 May 2026 Active
  • FDA GUDID UDI-DI 07290107275712 listed 7 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290107275712
  2. Registered EUDAMED 72911127StepDrillsST

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  • Withdrawn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
Tools
Generic name
Fixture/appliance dental drill bit, reusable
Device name
Coated Step Drills
Model / Ref / Catalog
TDCSt-2.2, 8
Primary DI / UDI-DI
07290107275712
Basic UDI-DI
72911127StepDrillsST
FDA product code
NDP
EMDN code
Z12110102 Dental drills
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Romania
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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS.

Other devices from A.B. Dental Devices Ltd

See all devices from A.B. Dental Devices Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)