Identity
- Trade Name
- 25K 90 ENDO INSERT FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- TU0201-002R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873120673 FDA UDI
- 510(k) Number
- K052028 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
25k 90 Endo Insert 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
K052028 also covers:
- 25K 120 ENDO INSERT — BONART CO., LTD.
- 25K IF-3 BEAVERTAIL INSERT — BONART CO., LTD.
- 25K MAGNET HANDPIECE WITH CABLE — BONART CO., LTD.
- 25K P1000 INSERT — BONART CO., LTD.
- 30K FS-10 PLASTIC INSERT — BONART CO., LTD.
- 30K FS-10 PLASTIC INSERT/Darby — BONART CO., LTD.
- 30K FS-SLIM PLASTIC INSERT — BONART CO., LTD.
- 30K FS-SLIM PLASTIC INSERT/Darby — BONART CO., LTD.
- 30K IF-5 BEAVERTAIL INSERT — BONART CO., LTD.
- 30K MAGNET HANDPIECE WITH CABLE — BONART CO., LTD.
- 30K P10 UNIVERSAL INSERT — BONART CO., LTD.
- 30K P100 UNIVERSAL INSERT — 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 c3c19ae2-f2d5-4383-b837-8c7f592290c6 33 fields · synced Jun 6, 2026