Identity
- Trade Name
- BSN2820 EUDAMEDBSN2028 EUDAMEDNeedle FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Beta Mini EUDAMED
- Model / Reference
- BP-B1 EUDAMEDnone EUDAMEDBSN2820 FDA UDIBSN2028 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019101512 EUDAMEDFDA UDI08800019101710 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191MINIMY EUDAMED
- 510(k) Number
- K060347 FDA UDI
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bsn2820 by B&L Biotech — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000191MINIMY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 02b0db7b-0e95-4ad9-ab20-b88203ce2695 61 fields · synced Jul 21, 2026
- EUDAMED 408e2698-f6c0-45c1-be19-d6190f79be4e 61 fields · synced May 18, 2026
- FDA UDI f21ac69b-f568-438c-8f4b-25054589d671 33 fields · synced May 30, 2026
- FDA UDI 50d430ec-df0f-4889-a21c-3551d56510dc 32 fields · synced May 30, 2026
- EUDAMED baf8ba4d-3795-4216-b475-47b523f75d27 61 fields · synced Jul 21, 2026