Identity
- Trade Name
- SONICflex prep crown plain No. 98 FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- 1.008.6385 FDA UDI
Identifiers
- Catalog Number
- prep crown plain No 98 FDA UDI
- Primary DI / UDI-DI
- EKAV100863850 FDA UDI
- 510(k) Number
- K073478 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system
SONICflex prep crown plain No. 98 by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073478 also covers:
- A-dec — A-Dec, Inc.
- A-dec — A-Dec, Inc.
- EXPERT LUX Case 680465LRN — KaVo Dental GmbH
- EXPERTmatic E15 C — KaVo Dental GmbH
- EXPERTmatic E15 L — KaVo Dental GmbH
- EXPERTmatic E20 C — KaVo Dental GmbH
- EXPERTmatic E25 C — KaVo Dental GmbH
- EXPERTmatic E25 L — KaVo Dental GmbH
- EXPERTmatic E31 C — KaVo Dental GmbH
- EXPERTtorque E675 LMW — KaVo Dental GmbH
- EXPERTtorque E679 L — KaVo Dental GmbH
- EXPERTtorque LUX E680 L — KaVo Dental GmbH
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
- KaVo Dental GmbH
Sources (1)
- FDA UDI 0377050f-a365-427b-9453-62eb3d2bf651 36 fields · synced May 30, 2026