Identity
- Trade Name
- B&L-Beta FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Model / Reference
- WL-B1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019101017 FDA UDI
- 510(k) Number
- K060347 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endodontic obturation system
B&L-Beta by B&L Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K060347 also covers:
- B&L-Beta(P) — B&L Biotech Co., Ltd.
- B&L-Beta(W) — B&L Biotech Co., Ltd.
- Beta Mini — B&L Biotech Co., Ltd.
- Beta Mini(P) — B&L Biotech Co., Ltd.
- Beta Mini(W) — B&L Biotech Co., Ltd.
- Needle — B&L Biotech Co., Ltd.
- Needle — B&L Biotech Co., Ltd.
- Needle — B&L Biotech Co., Ltd.
- Obtura Spartan — Young Innovations, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 5f8fe561-371b-45c8-a15e-b5452a6cbbe9 33 fields · synced Jun 6, 2026