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BSN2225

by B&L Biotech 2 variants

Part of a family of 22 devices: see the family page

Model BP-B1

BSN2225 (BP-B1) is an endodontic obturation system (EU MDR Class IIa; FDA Class I; FDA product code EKR, Plugger, Root Canal, Endodontic) made by B&L Biotech, registered in EUDAMED on 2 Oct 2024 (Basic UDI-DI 88000191MINIMY), cleared under FDA 510(k) K060347 on 5 Jun 2006 and listed in FDA GUDID since 21 May 2019 (UDI-DI 08800019101550), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060347

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000191MINIMY Basic UDI-DI 08800019101550UDI-DIDate2 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019101550 UDI-DI Date21 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060347 Date5 Jun 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000191MINIMY registered 2 Oct 2024 Active
  • FDA 510(k) K060347 decided 5 Jun 2006 Active
  • FDA GUDID UDI-DI 08800019101550 listed 21 May 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060347
  2. Listed FDA GUDID 08800019101550
  3. Registered EUDAMED 88000191MINIMY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
BSN2225 EUDAMED
Needle GUDID
Generic name
Endodontic obturation system
Device name
Beta Mini
Model / reference
BP-B1 EUDAMED
BSN2225 GUDID
Primary DI / UDI-DI
08800019101550
Basic UDI-DI
88000191MINIMY
510(k) Number
FDA product code
EKR
EMDN code
Q01010299 Root canal filling devices - other
GMDN term
Endodontic obturation system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BP-B1
none
GUDID
BSN2225
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 ROOT CANAL FILLING DEVICES - OTHER.

Other devices from B&L Biotech

  • Sprds

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  • BSN2123

    Class IIa

See all devices from B&L Biotech →

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)