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Nordent Manufacturing, Inc.

by Nordent Manufacturing Inc. 166 variants

Ref Nordent Catalogue Hygiene SectionModel RENSGRA13-14, RENSGRA15-16, RENS204SD, RPFI8A

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0840018679146U Basic UDI-DI Date3 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840018667914 UDI-DI Date19 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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 scaler, reusable
Periodontal curette
Device Name
Xdura Scaler De #204SD Dl-S Hd
Composite Placement, DE, Double Paddle #8A, Medium Round Handle
Model / Ref / Catalog
RENSGRA13-14, Nordent Catalogue Hygiene Section, RENSGRA15-16, RENS204SD, RPFI8A, Nordent Catalog Hygiene section
Primary DI / UDI-DI
00840018667914, 00840018667921, 00840018623224, 00840018659582
Basic UDI-DI
0840018679146U, 0840018679216R, 0840018632244Y, 08400186958277
FDA Product Code
ELA, EMS
EMDN Code
L159001, L159009, L15900699
GMDN Term
Manual dental scaler, reusable
Periodontal curette
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Atherectomy Cutter Length — 14 Inch

Manufacturer details

EUDAMED SRN
US-MF-000048439
Authorised representative
Ukens Dental DE-AR-000022084

Other devices from Nordent Manufacturing Inc

See all devices from Nordent Manufacturing Inc →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use NoGUDIDYesGUDID
  • Over-the-Counter NoGUDIDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No