Identity
- Trade Name
- BONE TIP/BM-EL3 FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Model / Reference
- BM-EL3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873121175 FDA UDI
- 510(k) Number
- K080761 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system
Bone Tip/Bm-El3 by Bonart Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system.
- DS Tip — B&L Biotech Co., Ltd. · Class I
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- TS Tip — B&L Biotech Co., Ltd. · Class I
- JETIP Bendable Jig — B&L Biotech Co., Ltd. · Class I
- TS Tip — B&L Biotech Co., Ltd. · Class I
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- ACTEON — Satelec · Class II
Cleared under the same submission
K080761 also covers:
- BONE TIP HOLDER SET (6 TIPS) — BONART CO., LTD.
- BONE TIP HOLDER SET (8 TIPS) — BONART CO., LTD.
- BONE TIP/BM-10P — BONART CO., LTD.
- BONE TIP/BM-1S — BONART CO., LTD.
- BONE TIP/BM-BS2L — BONART CO., LTD.
- BONE TIP/BM-BS2R — BONART CO., LTD.
- BONE TIP/BM-EL2 — BONART CO., LTD.
- BONE TIP/BM-EN03 — BONART CO., LTD.
- BONE TIP/BM-EX01 — BONART CO., LTD.
- BONE TIP/BM-EX01L — BONART CO., LTD.
- BONE TIP/BM-EX01R — BONART CO., LTD.
- BONE TIP/BM-HB01 — BONART CO., LTD.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA UDI 8061daf2-e1c2-47d6-a5a4-ff9b0cba9d08 33 fields · synced May 30, 2026