Identity
- Trade Name
- SONICflex paro Tip No. 60 (A) FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- This is a medical device. FDA UDI
- Model / Reference
- 1.006.1934 FDA UDI
- Description
- This is a medical device. FDA UDI
Identifiers
- Catalog Number
- paro Tip No 60 A FDA UDI
- Primary DI / UDI-DI
- EKAV100619340 FDA UDI
- 510(k) Number
- K080089 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental surgical power tool motor, pneumatic 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: Dental surgical power tool motor, pneumatic
SONICflex paro Tip No. 60 (A) by KaVo Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental surgical power tool motor, pneumatic.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KaVo Dental GmbH
Sources (1)
- FDA UDI b8417873-8ae4-4df2-9f78-787edbf6bf21 37 fields · synced May 30, 2026