Identity
- Trade Name
- SONICflex 2008 FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- This is a medical device.This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry. FDA UDI
- Model / Reference
- 1.005.9311 FDA UDI
- Description
- This is a medical device.This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry. FDA UDI
Identifiers
- Catalog Number
- 2008 FDA UDI
- Primary DI / UDI-DI
- EKAV100593110 FDA UDI
- 510(k) Number
- K080089 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
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
No
FDA UDI
Serial Number
Yes
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 2008 by KaVo Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080089 also covers:
- PiezoLED — KaVo Dental GmbH
- SONICflex 2003 L (Set) — KaVo Dental GmbH
- SONICflex 2008 L (Set) — KaVo Dental GmbH
- SONICflex 2008 L (Set) — KaVo Dental GmbH
- SONICflex 2008 LS — KaVo Dental GmbH
- SONICflex 2008 S — KaVo Dental GmbH
- SONICflex bevel Tip No. 59 — KaVo Dental GmbH
- SONICflex bevel Tip No. 59 (A) — KaVo Dental GmbH
- SONICflex bevel Tipset (A) — KaVo Dental GmbH
- SONICflex cari-ex 0.8 No. 42 — KaVo Dental GmbH
- SONICflex cari-ex 0.8 No. 42 (A) — KaVo Dental GmbH
- SONICflex cari-ex 1.0 No. 71 (A) — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KaVo Dental GmbH
Sources (1)
- FDA UDI 546a3636-2342-482d-9a05-8c9740e3e16c 37 fields · synced May 31, 2026