OnBrace Kit w/ Archwire Tubes

FDA UDI

Class I (US FDA UDI)

by Specialty Appliances, Llc

Identity

Trade Name: OnBrace Kit w/ Archwire Tubes FDA UDI
Generic Name: Preformed dental crown, temporary FDA UDI
Model / Reference: 901348 FDA UDI

Identifiers

Primary DI / UDI-DI: D8199013480 FDA UDI
FDA Product Code: ELZ FDA UDI
GMDN Term: Preformed dental crown, temporary FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3330 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Preformed dental crown, temporary

OnBrace Kit w/ Archwire Tubes by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Specialty Appliances, Llc

Sources (1)

FDA UDI 7ad625b3-57a4-45e0-9fb4-8c1b49609c2c 32 fields · synced Jun 8, 2026