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Nordent Manufacturing, Inc.

by Nordent Manufacturing Inc. 166 variants

Ref Nordent HygieneModel Implant Curette, DE, Titanium, ImplaMate Barnhart #5-6

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 Number0840018600003PL Basic UDI-DI 00840018600003UDI-DIDate30 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840018600003 UDI-DI Date28 Apr 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  • Withdrawn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

Trade Name
Nordent Manufacturing, Inc. EUDAMEDGUDID
Brasseler USA GUDID
Generic Name
Manual endodontic filling material spreader
Manual dental scaler, reusable
Device Name
Implant Scaler, De, Barnhart 5
Model / Ref / Catalog
Implant Curette, DE, Titanium, ImplaMate Barnhart #5-6, Nordent Hygiene, 5007773U0, ROPN2
Primary DI / UDI-DI
00840018600003, 00840018673854
Basic UDI-DI
0840018600003PL
FDA Product Code
EKK, ELA
EMDN Code
L159001 Dental and periodontal curettes, reusable
GMDN Term
Manual endodontic filling material spreader
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Implant Curette, DE, Titanium, ImplaMate Barnhart #5-6
Nordent Hygiene
GUDID
5007773U0
ROPN2

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

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

Other properties (17)

  • Sterile: 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