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Beta Mini

by B&L Biotech 2 variants

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

Model BP-B1

Beta Mini (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 24 May 2024 (Basic UDI-DI B-08800019101666) and listed in FDA GUDID since 15 Jun 2020 (UDI-DI 08800019101666), 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-08800019101666 Basic UDI-DI 08800019101666UDI-DIDate24 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800019101666 Basic UDI-DI 08800019101666UDI-DIDate24 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019101666 UDI-DI Date15 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800019101666 registered 24 May 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800019101666 listed 15 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019101666
  2. Registered EUDAMED B-08800019101666

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  • Withdrawn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

Trade name
Beta Mini EUDAMED
Beta Mini(W) GUDID
Generic name
Endodontic obturation system
Model / reference
BP-B1
Primary DI / UDI-DI
08800019101666
Basic UDI-DI
B-08800019101666, 88000191MINIMY
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
Legacy device (under a directive)
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08800019101666: EUDAMED states Yes, FDA GUDID states No.

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 YesEUDAMEDNoGUDID
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)