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Leetrac

by B&L Biotech 14 variants

Part of a family of 16 devices: see the family page

Model LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR, LTNBT

Leetrac is a periosteal elevator (EU MDR Class I; FDA Class I; FDA product code EMO, Knife, Periodontic) made by B&L Biotech, registered in EUDAMED on 13 Apr 2024 (Basic UDI-DI 88000191LEETRACK4) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019110958), active as of 22 Oct 2026.

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

CE MDR

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 Number88000191LEETRACK4 Basic UDI-DI 08800019110958UDI-DIDate13 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019110958 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191LEETRACK4 registered 13 Apr 2024 Active
  • FDA GUDID UDI-DI 08800019110958 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019110958
  2. Registered EUDAMED 88000191LEETRACK4

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  • Withdrawn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
Leetrac EUDAMED
Leetrac Narrow Blade GUDID
Generic name
Periosteal elevator, reusable
Model / reference
LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR
Primary DI / UDI-DI
08800019110958
Basic UDI-DI
88000191LEETRACK4, B-08800019110958
FDA product code
EMO
EMDN code
L150201 Dental retractors, reusable
GMDN term
Periosteal elevator, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
Legacy device (under a directive)
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.

Other devices from B&L Biotech

  • Sprds

    Class IIa

  • Sprdn

    Class IIa

  • Leetrac

    Class I

  • BSN2123

    Class IIa

See all devices from B&L Biotech →

Properties

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