FlexiWheel

FDA UDI

Class I (US FDA UDI)

by Cosmedent, Inc.

Identity

Trade Name: FlexiWheel FDA UDI
Generic Name: Dental abrasive disk, single-use FDA UDI
Device Name: FlexiWheels Superfine Pink FDA UDI
Model / Reference: 403502 FDA UDI
Description: FlexiWheels Superfine Pink FDA UDI

Identifiers

Primary DI / UDI-DI: D77940305216 FDA UDI
FDA Product Code: EHJ FDA UDI
GMDN Term: Dental abrasive disk, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental abrasive disk, single-use

FlexiWheel by Cosmedent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive disk, single-use.

PRAXIS — TDV DENTAL LTDA · Class I
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The Orthodontic Store — Young Innovations, Inc. · Class I
PRAXIS — TDV DENTAL LTDA · Class I
PRAXIS — TDV DENTAL LTDA · Class I
PRAXIS — TDV DENTAL LTDA · Class I
SeptoDiscs Refill: 1/2” - 50 fine abrasive discs — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
SANDPAPER DISCS — TDV DENTAL LTDA · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Cosmedent, Inc.

Sources (1)

FDA UDI fba47e97-dd93-4659-9808-ee6c69b44487 33 fields · synced May 30, 2026