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Black Brush #1 Bent

by Cosmedent, Inc.

Ref 201211

Black Brush #1 Bent (201211) is a Class I device made by Cosmedent, Inc., registered in EUDAMED on 12 Mar 2026 (Basic UDI-DI ++D779BRUSH101CD) and listed in FDA GUDID since 26 Oct 2021 (UDI-DI D7792012110), 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 Number++D779BRUSH101CD Basic UDI-DI D7792012110UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD7792012110 UDI-DI Date26 Oct 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D779BRUSH101CD registered 12 Mar 2026 Active
  • FDA GUDID UDI-DI D7792012110 listed 26 Oct 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D7792012110
  2. Registered EUDAMED ++D779BRUSH101CD

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  • Withdrawn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
Black Brush #1 Bent EUDAMED
Brush Black #1 Bent GUDID
Generic name
Dental-professional prophylaxis brush, reusable
Device name
Black Brush
Model / reference
201211
Primary DI / UDI-DI
D7792012110 EUDAMED
D7792012111 GUDID
Basic UDI-DI
++D779BRUSH101CD
FDA product code
KXR
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental-professional prophylaxis brush, reusable
Device class
Class I
Regulation number
872.3140
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D7792012110
GUDID
D7792012111

The registries describe this device under different primary UDI-DIs (EUDAMED lists D7792012110; FDA GUDID lists D7792012111), so their flags are not compared.

Manufacturer details

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

Similar devices in this category

Other devices filed under DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE.

Other devices from Cosmedent, Inc.

See all devices from Cosmedent, Inc. →

Properties

  • Prescription use
  • Premarket exempt
Other properties (23, all answered No)