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Diatech Diamond Instruments 200650AA

by Coltène/Whaledent AG

Ref 200650AAModel DIATECH Diamond Instruments

Diatech Diamond Instruments 200650AA is a device classified as Class IIa in the EU and Class I in the US made by Coltène/Whaledent AG, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-J006200650AA0) and listed in FDA GUDID since 31 Jul 2022 (UDI-DI J006200650AA0), active as of 7 Nov 2026.

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

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 NumberB-J006200650AA0 Basic UDI-DI J006200650AA0UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ006200650AA0 UDI-DI Date31 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-J006200650AA0 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI J006200650AA0 listed 31 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID J006200650AA0
  2. Registered EUDAMED B-J006200650AA0

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
G879-314-012-10-F EUDAMED
Diatech Diamond Instruments GUDID
Generic name
Diamond dental bur, reusable
Model / Ref / Catalog
200650AA, DIATECH Diamond Instruments
Primary DI / UDI-DI
J006200650AA0
Basic UDI-DI
B-J006200650AA0
FDA product code
DZP
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Diamond dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4535
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI J006200650AA0: EUDAMED states No, FDA GUDID states Yes.

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: Diamond dental bur, reusable

Similar devices in this category

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

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)