Custom Digital Orthodontics

FDA UDI

Class I (US FDA UDI)

by Klowen Braces, Inc.

Identity

Trade Name: Custom Digital Orthodontics FDA UDI
Generic Name: Orthodontic appliance/positioning tray kit FDA UDI
Device Name: Custom brackets and disposable resin applicator tray. FDA UDI
Model / Reference: CIBM-100001 FDA UDI
Description: Custom brackets and disposable resin applicator tray. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850061082015 FDA UDI
FDA Product Code: QJJ FDA UDI
GMDN Term: Orthodontic appliance/positioning tray kit 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

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

Yes

FDA UDI

Category: Orthodontic appliance/positioning tray kit

Custom Digital Orthodontics by Klowen Braces, 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: Klowen Braces, Inc.

Sources (1)

FDA UDI cfa2c573-bc97-4ccc-84c5-5a546c85c172 34 fields · synced May 30, 2026