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Virage Ceramic Brackets

FDA UDI

Class II (US FDA UDI)

by American Orthodontics

Identity

Trade Name
Virage Ceramic Brackets FDA UDI
Generic Name
Orthodontic bracket, ceramic FDA UDI
Device Name
COSMETIC VIRAGE LL CUSPID 022 T=0 A+3 R=0 FDA UDI
Model / Reference
002-2034V FDA UDI
Description
COSMETIC VIRAGE LL CUSPID 022 T=0 A+3 R=0 FDA UDI

Identifiers

Catalog Number
002-2034V FDA UDI
Primary DI / UDI-DI
00190746007040 FDA UDI
510(k) Number
K922499 FDA UDI
FDA Product Code
NJM FDA UDI
GMDN Term
Orthodontic bracket, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Virage Ceramic Brackets by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K922499 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Orthodontics

Sources (1)

  • FDA UDI f11755ec-afbb-4f23-9dec-9b1d241a7339 37 fields · synced Jun 9, 2026