Skip to content

Praxis 0002000048

by Tdv Dental Ltda

Part of a family of 72 devices: see the family page

Ref 0002000048Model FINISHING AND POLISHING DISCS, PRAXIS

Praxis 0002000048 is a dental abrasive disk (EU MDD Class IIa; FDA Class I; FDA product code EHJ, Disk, Abrasive) made by Tdv Dental Ltda, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 7897990300200HQ) and listed in FDA GUDID since 28 Feb 2025 (UDI-DI 07897990300738), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number7897990300200HQ Basic UDI-DI 07897990300738UDI-DIDate20 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number7897990300200HQ Basic UDI-DI 07897990300738UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07897990300738 UDI-DI Date28 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7897990300200HQ registered 20 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07897990300738 listed 28 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07897990300738
  2. Registered EUDAMED 7897990300200HQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Praxis
Generic name
Dental abrasive disk, single-use
Device name
Finishing and Polishing Discs
Model / Ref / Catalog
0002000048, FINISHING AND POLISHING DISCS, PRAXIS
Primary DI / UDI-DI
07897990300738
Basic UDI-DI
7897990300200HQ, B-07897990300738
FDA product code
EHJ
EMDN code
Q010501 Dental burs and abrasive disks, single-use
GMDN term
Dental abrasive disk, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6010
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Dental abrasive disk, single-use

Similar devices in this category

Other devices filed under DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE.

Other devices from Tdv Dental Ltda

See all devices from Tdv Dental Ltda →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)