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Clear Advantage

FDA UDI

Class I (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name
Clear Advantage FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Splint Material .080“ 25 sheets per pack FDA UDI
Model / Reference
7500-040 FDA UDI
Description
Splint Material .080“ 25 sheets per pack FDA UDI

Identifiers

Primary DI / UDI-DI
00190730084576 FDA UDI
FDA Product Code
KMY FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Clear Advantage by Ortho Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Technology, Inc.

Sources (1)

  • FDA UDI 0d6ba61a-f32c-4fad-9034-b13256f00cb8 33 fields · synced May 30, 2026