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Mini FlexiBuff

by Cosmedent, Inc. 3 variants

Ref 402612, 402138, 402258, 402588, 402412, 402112, 402358

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D779DISCBUFF101BV Basic UDI-DI Date22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD7794026120 UDI-DI Date22 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
FlexiDisc Mini 3/8 Coarse
FlexiDisc Mini 1/2 Coarse
FlexiBuff Mini 1/2
FlexiDisc Mini 1/2 Superfine
FlexiDisc Mini 5/8 Medium
FlexiDisc Mini 5/8 Fine
FlexiDisc Mini 5/8 Coarse Sand
Generic Name
Dental abrasive disk, single-use
Hydrogen peroxide (H2O2) IVD, kit, electrometry
Device Name
Mini FlexiBuff
Model / Reference
402612, 402138, 402112, 402412, 402258, 402358, 402588
Primary DI / UDI-DI
D7794026120 EUDAMED
D7794021380 EUDAMED
D7794022580 EUDAMED
D779402588 EUDAMED
D7794024120 EUDAMED
D7794021120 EUDAMED
D7794023580 EUDAMED
D7794021381 GUDID
D77940211212 GUDID
D77940261217 GUDID
D77940241215 GUDID
D7794022581 GUDID
D7794023581 GUDID
D7794025881 GUDID
Basic UDI-DI
++D779DISCBUFF101BV
FDA Product Code
EHJ
EMDN Code
Q01010403 Dental abrasive and polishing materials
GMDN Term
Dental abrasive disk, single-use
Hydrogen peroxide (H2O2) IVD, kit, electrometry
Device Class
Class I
Regulation Number
872.6010
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D7794026120
D7794021380
D7794022580
D779402588
D7794024120
D7794021120
D7794023580
GUDID
D7794021381
D77940211212
D77940261217
D77940241215
D7794022581
D7794023581
D7794025881

Manufacturer details

EUDAMED SRN
US-MF-000045496
Authorised representative
SAS Exclusivas Dentales S.L. ES-AR-000045423

Other devices from Cosmedent, Inc.

See all devices from Cosmedent, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No