Identity
- Trade Name
- SONICflex retro Tip No. 55 FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- 0.571.7342 FDA UDI
Identifiers
- Catalog Number
- retro Tip No 55 FDA UDI
- Primary DI / UDI-DI
- EKAV057173420 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
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 retro Tip No. 55 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 — 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
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
- KaVo Dental GmbH
Sources (1)
- FDA UDI 74c0ef34-c2cd-41b9-a241-563d11b84a46 36 fields · synced Jun 8, 2026