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Diamantstreifen

by NTI-Kahla GmbH Rotary Dental Instruments 11 variants

Ref FS2-M

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E310DiaStFuellDF Basic UDI-DI +E310FS2M1UDI-DIDate16 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number+E310FS2M1 UDI-DI Date1 Jan 2022ListedStatusListed 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  • Withdrawn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
Diamantstreifen EUDAMED
Nti GUDID
Generic Name
Dental abrasive strip, reusable
Model / Ref / Catalog
FS2-M
Primary DI / UDI-DI
+E310FS2M1 EUDAMED
E310FS2M1 GUDID
Basic UDI-DI
++E310DiaStFuellDF
Unit of Use DI
+E310FS2M0
FDA Product Code
DZP
EMDN Code
L159019 Dental finishing rasps and files, reusable
GMDN Term
Dental abrasive strip, reusable
Device Class
Class I
Regulation Number
872.4535
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E310FS2M1
GUDID
E310FS2M1

Manufacturer details

EUDAMED SRN
DE-MF-000009451

Other devices from NTI - Kahla GmbH Rotary Dental Instruments

See all devices from NTI - Kahla GmbH Rotary Dental Instruments →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No