Identity
- Trade Name
- SONICflex retro Tip No. 20 FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- Powered scalers EUDAMEDThis is a medical device.This is a medical device. FDA UDI
- Model / Reference
- 0.571.5521 EUDAMEDFDA UDI
- Description
- This is a medical device.This is a medical device. FDA UDI
Identifiers
- Catalog Number
- retro Tip No 20 FDA UDI
- Primary DI / UDI-DI
- EKAV057155210 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EKAVG503Z7 EUDAMED
- 510(k) Number
- K080089 FDA UDI
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ultrasonic dental scaling/debridement system
SONICflex retro Tip No. 20 by KaVo Dental GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ultrasonic dental scaling/debridement system.
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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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 822dcd44-15db-48d7-b4fc-5c710ff99ab1 37 fields · synced Oct 7, 2026
- EUDAMED c4dda2cd-72aa-4a72-91cb-6ef2ec969f0c 61 fields · synced Oct 7, 2026