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BP4004

by B&L Biotech

Part of a family of 14 devices: see the family page

Model CL-A1

BP4004 (CL-A1) 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 88000191ALPHAFS) and listed in FDA GUDID since 21 May 2019 (UDI-DI 08800019100164), 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 Number88000191ALPHAFS Basic UDI-DI 08800019100164UDI-DIDate2 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019100164 UDI-DI Date21 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000191ALPHAFS registered 2 Oct 2024 Active
  • FDA GUDID UDI-DI 08800019100164 listed 21 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019100164
  2. Registered EUDAMED 88000191ALPHAFS

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  • Withdrawn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
BP4004 EUDAMED
Plugger GUDID
Generic name
Endodontic obturation system
Device name
SuperEndo-Alpha II
Model / reference
CL-A1 EUDAMED
BP4004 GUDID
Primary DI / UDI-DI
08800019100164
Basic UDI-DI
88000191ALPHAFS
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
CL-A1
none
GUDID
BP4004
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.

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Properties

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