Experience®

FDA UDI

Class I (US FDA UDI)

by GC Orthodontics America Inc.

Identity

Trade Name: EXPERIENCE® FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: EXPC/M ROTH 022 UL 7-7 HK 3,4,5 FDA UDI
Model / Reference: 11/20-2AA5-9380 FDA UDI
Description: EXPC/M ROTH 022 UL 7-7 HK 3,4,5 FDA UDI

Identifiers

Catalog Number: 11/20-2AA5-9380 FDA UDI
Primary DI / UDI-DI: D78811202AA593801 FDA UDI
FDA Product Code: EJF FDA UDI
NJM FDA UDI
GMDN Term: Orthodontic bracket, ceramic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
872.5470 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic bracket, metal Orthodontic bracket, ceramic

Experience® by GC Orthodontics America Inc. — 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: GC Orthodontics America Inc.

Sources (1)

FDA UDI 6283055b-1f40-4389-b8b5-aa776b74e408 35 fields · synced May 30, 2026