Colgate Optic White Professional In Office Whitening Kit

FDA UDI

Class I (US FDA UDI)

by Colgate Oral Pharmaceuticals, Inc.

Identity

Trade Name: Colgate Optic White Professional In Office 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 serum, once applied with the precision brush, quickly forms a smudge-proof, concentrated hydrogen peroxide film on the patient's teeth. The LED device then uses the light energy to amplify the whitening power of the concentrated film even further. FDA UDI
Model / Reference: 61020117 FDA UDI
Description: Colgate® Optic White® Professional features a synergistic combination of a quick-dry whitening serum and a rechargeable LED whitening device. The serum, once applied with the precision brush, quickly forms a smudge-proof, concentrated hydrogen peroxide film on the patient's teeth. The LED device then uses the light energy to amplify the whitening power of the concentrated film even further. FDA UDI

Identifiers

Primary DI / UDI-DI: 00827854000587 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

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Manufacturing Date

FDA UDI

Category: Tooth-bleaching acceleration unit

Colgate Optic White Professional In Office 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 6c905f3f-ab2d-4a8b-9752-759e2558d4e5 34 fields · synced May 29, 2026