Mini Master Series

FDA UDI

Class I (US FDA UDI)

by American Orthodontics

Identity

Trade Name: Mini Master Series FDA UDI
Generic Name: Orthodontic bracket, metal FDA UDI
Device Name: 1 PAT SETUP MINI MS ROTH 022 U/L 6X6 W/HK 3,4,5 LP TUBES STICKY FDA UDI
Model / Reference: 126-025387 FDA UDI
Description: 1 PAT SETUP MINI MS ROTH 022 U/L 6X6 W/HK 3,4,5 LP TUBES STICKY FDA UDI

Identifiers

Catalog Number: 126-025387 FDA UDI
Primary DI / UDI-DI: 00190746150500 FDA UDI
510(k) Number: K122753 FDA UDI
FDA Product Code: EJF FDA UDI
GMDN Term: Orthodontic bracket, metal FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthodontic bracket, metal

Mini Master Series by American Orthodontics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, metal.

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LEGEND — GC Orthodontics America Inc. · Class I
MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
RMO — RMO · Class I
Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
Votion — ORTHO TECHNOLOGY, INC. · Class I

Cleared under the same submission

K122753 also covers:

Mini Master Series — American Orthodontics

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: American Orthodontics

Sources (1)

FDA UDI a4ad6748-3b68-4472-9ab5-0bcf19a08f29 36 fields · synced Jun 9, 2026