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Kimtrac

by B&L Biotech 30 variants

Part of a family of 30 devices: see the family page

Model KTNNH, KTR-M1S, KTR-M2S, KTR-M3S, KTR-M4S, KTR-M5S, KTR-P1S, KTR-P2S, KTR-M1N, KTR-M2N, KTR-M3N, KTR-M4N, KTR-M5N, KTR-P1N, KTR-P2N, KTN1S, KTN2S, KTN3S, KTN4S, KTNNH, KTN1N, KTN2N, KTN3N, KTN4N

Kimtrac (KTNNH) is a periosteal elevator (EU MDR Class I; FDA Class I; FDA product code NDP, Accessories, Implant, Dental, Endosseous) made by B&L Biotech, registered in EUDAMED on 24 May 2024 (Basic UDI-DI B-08800019111238) and listed in FDA GUDID since 28 Oct 2022 (UDI-DI 08800019111238), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08800019111238 Basic UDI-DI 08800019111238UDI-DIDate24 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800019111238 Basic UDI-DI 08800019111238UDI-DIDate24 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019111238 UDI-DI Date28 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800019111238 registered 24 May 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800019111238 listed 28 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019111238
  2. Registered EUDAMED B-08800019111238

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Periosteal elevator, reusable
Model / reference
KTNNH, KTR-M1S, KTR-M2S, KTR-M3S, KTR-M4S, KTR-M5S, KTR-P1S, KTR-P2S, KTR-M1N, KTR-M2N, KTR-M3N, KTR-M4N, KTR-M5N, KTR-P1N, KTR-P2N, KTN1S, KTN2S, KTN3S, KTN4S, KTN1N, KTN2N, KTN3N, KTN4N
Primary DI / UDI-DI
08800019111238
Basic UDI-DI
B-08800019111238, 88000191KIMTRACNX
FDA product code
NDP
EMDN code
L150201 Dental retractors, reusable
GMDN term
Periosteal elevator, reusable
Device class
Class I
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under DENTAL RETRACTORS, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)