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Hu-Friedy

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

Part of a family of 101 devices: see the family page

Ref RCSD11TXModel Dental Intruments

Hu-Friedy (RCSD11TX) is a Class I device made by Hu-Friedy Manufacturing Co., LLC, registered in EUDAMED on 3 Apr 2025 (Basic UDI-DI 0889950Place1R5C) and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 10889950105488), 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
European UnionCE/MDR EUDAMED Number0889950Place1R5C Basic UDI-DI 10889950105488UDI-DIDate3 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950105488 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0889950Place1R5C registered 3 Apr 2025 Active
  • FDA GUDID UDI-DI 10889950105488 listed 14 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10889950105488
  2. Registered EUDAMED 0889950Place1R5C

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  • Withdrawn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 endodontic filling material spreader
Model / Ref / Catalog
Dental Intruments, RCSD11TX
Primary DI / UDI-DI
10889950105488
Basic UDI-DI
0889950Place1R5C
FDA product code
EKK
EMDN code
Q01010202 Root canal filling dental cements
GMDN term
Manual endodontic filling material spreader
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: Calcium hydroxide dental cement

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL CEMENTS.

Other devices from Hu-Friedy Manufacturing Co., LLC

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Properties

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