Identity
- Trade Name
- BSN5020 EUDAMEDNeedle FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Beta Mini EUDAMED
- Model / Reference
- BSN5020 EUDAMEDFDA UDIBP-B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019101581 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191MINIMY EUDAMED
- 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
Yes
FDA 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
Category: Endodontic obturation system
Needle by B&L Biotech Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic obturation system.
- EndoPilot D-Pack — Schlumbohm GmbH & Co. KG · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- DUO-GUN — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- DUO-PEN — DiaDent Group International · Class I
- elements IC — META SYSTEMS CO., LTD. · Class I
- DIA-PEN — DiaDent Group International · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech Co., Ltd.
Sources (2)
- FDA UDI 9b1769b0-de0c-47af-8cb0-a58f921935ae 32 fields · synced Jul 8, 2026
- EUDAMED 6e8b69f5-155c-4f3f-9402-5273e70066f9 61 fields · synced Jun 18, 2026