Identity
- Trade Name
- BIS FOOT PEDAL CABLE FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Model / Reference
- PP4001-172R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873120314 FDA UDI
- 510(k) Number
- K152125 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental ultrasonic surgical system
Bis Foot Pedal Cable 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
K152125 also covers:
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 |
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Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA UDI e5a07516-5ddd-4995-8189-d99e544f92f5 33 fields · synced May 30, 2026