RONDOflex powder 50m (1000g)

FDA UDI

Class II (US FDA UDI)

by KaVo Dental GmbH

Identity

Trade Name: RONDOflex powder 50m (1000g) FDA UDI
Generic Name: Professional dental abrasive material FDA UDI
Model / Reference: 1.000.5956 FDA UDI

Identifiers

Catalog Number: NA FDA UDI
Primary DI / UDI-DI: EKAV100059560 FDA UDI
510(k) Number: K042872 FDA UDI
FDA Product Code: KOJ FDA UDI
GMDN Term: Professional dental abrasive material 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Professional dental abrasive material

RONDOflex powder 50m (1000g) 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

K042872 also covers:

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 e1d39a37-19a2-46a3-8d04-0c3ad6aa28c8 36 fields · synced May 30, 2026