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RONDOflex plus 360

FDA UDI

Class II (US FDA UDI)

by KaVo Dental GmbH

Identity

Trade Name
RONDOflex plus 360 FDA UDI
Generic Name
Dental power tool system handpiece, line-powered FDA UDI
Device Name
This is a medical device.This is a medical device. FDA UDI
Model / Reference
1.002.2179 FDA UDI
Description
This is a medical device.This is a medical device. FDA UDI

Identifiers

Catalog Number
plus 360 FDA UDI
Primary DI / UDI-DI
EKAV100221790 FDA UDI
510(k) Number
K042872 FDA UDI
FDA Product Code
KOJ FDA UDI
GMDN Term
Dental power tool system handpiece, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6080 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

Category: Dental power tool system handpiece, line-powered

RONDOflex plus 360 by KaVo Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool system handpiece, line-powered.

Cleared under the same submission

K042872 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KaVo Dental GmbH

Sources (1)

  • FDA UDI 2e54658c-8cd2-4394-9c4a-bb1edf2dad43 37 fields · synced May 31, 2026