Signature III bracket

FDA UDI

Class II (US FDA UDI)

by Rmo

Identity

Trade Name: Signature III bracket FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: Orthodontic ceramic bracket FDA UDI
Model / Reference: 0Q03011 FDA UDI
Description: Orthodontic ceramic bracket FDA UDI

Identifiers

Primary DI / UDI-DI: 00885797004260 FDA UDI
510(k) Number: K120471 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: 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Orthodontic bracket, ceramic

Signature III bracket by Rmo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Experience — GC Orthodontics America Inc. · Class II
Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
EXPERIENCE® — GC Orthodontics America Inc. · Class II
APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Rmo

Sources (1)

FDA UDI ad6fce6e-aa6c-4658-9c0f-80a75734e6ea 34 fields · synced May 30, 2026