Dtc

FDA UDI

Class I (US FDA UDI)

by Hangzhou DTC Medical Apparatus Co., Ltd.

Identity

Trade Name: DTC FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: Sapphire brackets FDA UDI
Model / Reference: 0.018/0.022 FDA UDI
Description: Sapphire brackets FDA UDI

Identifiers

Primary DI / UDI-DI: 06973554430507 FDA UDI
FDA Product Code: ECQ FDA UDI
GMDN Term: Orthodontic bracket, ceramic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthodontic bracket, ceramic

Dtc by Hangzhou DTC Medical Apparatus Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, ceramic.

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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 I	Pending data

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Manufacturer

Manufacturer: Hangzhou DTC Medical Apparatus Co., Ltd.

Sources (1)

FDA UDI b6e2334a-ed9b-4f6c-9b96-e1f9fea4b8a8 33 fields · synced May 30, 2026