Identity
- Trade Name
- PIEZO Tip BE-1 FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- BE-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873121113 FDA UDI
- 510(k) Number
- K071981 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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: Ultrasonic dental scaling/debridement system
PIEZO Tip BE-1 by Bonart Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071981 also covers:
- FOOT PEDAL FOR P6 — BONART CO., LTD.
- P6 TRANSFORMER -115V — BONART CO., LTD.
- PIEZO ELECTRIC ULTRASONIC SCALER — BONART CO., LTD.
- PIEZO ELECTRIC ULTRASONIC SCALER(LED) — BONART CO., LTD.
- PIEZO HANDPIECE — BONART CO., LTD.
- PIEZO LED HANDPIECE — BONART CO., LTD.
- PIEZO TIP BS-PFU — BONART CO., LTD.
- PIEZO TIP/BE-P — BONART CO., LTD.
- PIEZO Tip BE-2 — BONART CO., LTD.
- PIEZO Tip BE-3 — BONART CO., LTD.
- PIEZO Tip BE-PS — BONART CO., LTD.
- PIEZO Tip BS-1 — 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 |
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Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA UDI 5864c87d-b9b6-4e0e-8b2f-f1578bc17ee0 33 fields · synced May 29, 2026