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PROPHYflex 4 Flamingo

FDA UDI

Class I (US FDA UDI)

by KaVo Dental GmbH

Identity

Trade Name
PROPHYflex 4 Flamingo FDA UDI
Generic Name
Dental abrasive air jet system handpiece FDA UDI
Device Name
This is a medical device.This is a medical device. FDA UDI
Model / Reference
3.002.8800 FDA UDI
Description
This is a medical device.This is a medical device. FDA UDI

Identifiers

Catalog Number
PROPHYflex 4 Flamingo FDA UDI
Primary DI / UDI-DI
EKAV300288000 FDA UDI
510(k) Number
K181110 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental abrasive air jet system handpiece FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive air jet system handpiece

PROPHYflex 4 Flamingo by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive air jet system handpiece.

Cleared under the same submission

K181110 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 ee9b6d85-3f69-400b-af14-2a0cc5c304a6 37 fields · synced May 30, 2026