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NiTin™ NT-KMN-01

by Garrison Dental Solutions, L.L.C.

Ref NT-KMN-01

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 Number081003809BandsTFXZ Basic UDI-DI 00810038095943UDI-DIDate30 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810038095943 UDI-DI Date24 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  • Withdrawn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
NiTin™ Sectional Matrix Kit EUDAMED
NiTin™ GUDID
Generic Name
Dental matrix band kit
Device Name
Bands Family
Model / Ref / Catalog
NT-KMN-01
Description
Sectional Matrix Kit: (100) Full Curve Matrices, (100) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps, (1) Band Forceps
Primary DI / UDI-DI
00810038095943
Basic UDI-DI
081003809BandsTFXZ
FDA Product Code
JEP
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental matrix band kit
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

Other devices from Garrison Dental Solutions LLC

See all devices from Garrison Dental Solutions LLC →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No