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The Orthodontic Store

FDA UDI

Class II (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name
The Orthodontic Store FDA UDI
Generic Name
Dental acrylic resin kit FDA UDI
Device Name
Easy Etch Kit FDA UDI
Model / Reference
J0498 FDA UDI
Description
Easy Etch Kit FDA UDI

Identifiers

Catalog Number
J0498 FDA UDI
Primary DI / UDI-DI
00840326403549 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dental acrylic resin kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental acrylic resin kit

The Orthodontic Store by Young Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental acrylic resin kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA UDI 72d9b8f7-4780-4d77-9d4e-98bcbffe9285 35 fields · synced Jun 1, 2026