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Nordent Manufacturing, Inc.

by Nordent Manufacturing Inc. 166 variants

Ref Nordent Catalogue Hygiene SectionModel RENSGRA5-6, RENSGRA13-14L, RENSGRA7-8L, RENSGRA9-10, RENSM0-00, RENSGRA7-8, RENSGRA11-12, RENSGRA1-2

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
United StatesGUDID listing GUDID Number00840018671850 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0840018618505H Basic UDI-DI Date3 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Periodontal curette
Manual dental scaler, reusable
Device Name
Xdura, Curette, DE, Gracey #11-12, DuraLite® Round Handle
Model / Ref / Catalog
RENSGRA5-6, Nordent Catalogue Hygiene Section, RENSGRA13-14L, RENSGRA7-8L, RENSGRA9-10, RENSM0-00, RENSGRA7-8, RENSGRA11-12, RENSGRA1-2, Jaquette Morse #0-00, Nordent Catalog Hygiene section
Primary DI / UDI-DI
00840018671850, 00840018667907, 00840018667952, 00840018667976, 00840018667761, 00840018667969, 00840018667860, 00840018667891
Basic UDI-DI
0840018618505H, 0840018679076X, 08400186795274, 0840018679767J, 0840018677616T, 0840018679697M, 0840018678606W, 08400186789179
FDA Product Code
EMS, ELA
EMDN Code
L159001, L159009
GMDN Term
Periodontal curette
Manual dental scaler, reusable
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
Atherectomy Cutter Length — 14 Inch
Balloon 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
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number NoGUDIDYesGUDID
  • Manufacturing Date

Other properties (17)

  • 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
  • Expiration Date: No