Colgate Optic White Professional Take-Home Whitening Kit

FDA UDI

Class I (US FDA UDI)

by Colgate Oral Pharmaceuticals, Inc.

Identity

Trade Name: Colgate Optic White Professional Take-Home Whitening Kit FDA UDI
Generic Name: Tooth-bleaching acceleration unit FDA UDI
Device Name: Colgate® Optic White® Professional features a synergistic combination of a quick-dry whitening serum and a rechargeable LED whitening device. The patented formula is designed for no tooth sensitivity, no gum irritation, and no mess. The patented LED device accelerates whitening with a short 10-minute wear time. FDA UDI
Model / Reference: 61012561 FDA UDI
Description: Colgate® Optic White® Professional features a synergistic combination of a quick-dry whitening serum and a rechargeable LED whitening device. The patented formula is designed for no tooth sensitivity, no gum irritation, and no mess. The patented LED device accelerates whitening with a short 10-minute wear time. FDA UDI

Identifiers

Primary DI / UDI-DI: 00035000990754 FDA UDI
FDA Product Code: EEG FDA UDI
GMDN Term: Tooth-bleaching acceleration unit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6475 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

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: Tooth-bleaching acceleration unit

Colgate Optic White Professional Take-Home Whitening Kit by Colgate Oral Pharmaceuticals, Inc. — Class I — FDA UDI — listed in FDA GUDID

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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: Colgate Oral Pharmaceuticals, Inc.

Sources (1)

FDA UDI 9aacd2c5-07fd-433c-a27f-111126e200fd 34 fields · synced Jun 8, 2026