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Nordent Manufacturing, Inc.

by Nordent Manufacturing Inc. 166 variants

Ref Nordent Catalogue Hygiene SectionModel RPFI4, RENSJ1S-N5, RENSGRA11-12L

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0840018695136L Basic UDI-DI Date4 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840018659513 UDI-DI Date21 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  • Withdrawn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
Composite Placement, DE, Double Paddle #4, Medium Round Handle
Xdura Scaler De J1S-N5 Dl-R Hd
Model / Ref / Catalog
RPFI4, Nordent Catalogue Hygiene Section, RENSJ1S-N5, RENSGRA11-12L, Nordent Hygiene Catalog
Primary DI / UDI-DI
00840018659513, 00840018623712, 00840018667853
Basic UDI-DI
0840018695136L, 0840018637125J, 0840018678536Z
FDA Product Code
ELA, EMS
EMDN Code
L15900699, L159009, L159001
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
Length — 6.5 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
  • 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