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Hu-Friedy

by Hu-Friedy Manufacturing Co., LLC 1,000+ variants

Ref CTNBB27/29Model Dental Device

Hu-Friedy (CTNBB27/29) is a Class I device made by Hu-Friedy Manufacturing Co., LLC, registered in EUDAMED on 1 Jul 2025 (Basic UDI-DI 0889950Place1RU) and listed in FDA GUDID since 24 Feb 2026 (UDI-DI 10889950147761), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10889950147761 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0889950Place1RU Basic UDI-DI 10889950147761UDI-DIDate1 Jul 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0889950Place1RU registered 1 Jul 2025 Active
  • FDA GUDID UDI-DI 10889950147761 listed 24 Feb 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0889950Place1RU
  2. Listed FDA GUDID 10889950147761

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  • Withdrawn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

Generic name
Manual dental burnisher, reusable
Model / reference
Dental Device, CTNBB27/29
Primary DI / UDI-DI
10889950147761
Basic UDI-DI
0889950Place1RU
FDA product code
EKJ
EMDN code
Q01010103 Dental restorative composites
GMDN term
Manual dental burnisher, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000017104
Authorised representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Hu-Friedy Manufacturing Co., LLC

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)