Perio Sciences LED Tooth Whitener

FDA UDI

Class I (US FDA UDI)

by Perio Sciences, LLC

Identity

Trade Name: Perio Sciences LED Tooth Whitener FDA UDI
Generic Name: Teeth whitening kit FDA UDI
Device Name: This device utilizes a tooth whitening tray which surrounds the teeth and holds a whitening formulation during the teeth whitening procedure. The whitening formulation is supplied in three single use pens. The device is fitted with blue and red LED lights to simultaneously help enhance the bleaching procedure and protect the gums and soft tissues. FDA UDI
Model / Reference: 10620 FDA UDI
Description: This device utilizes a tooth whitening tray which surrounds the teeth and holds a whitening formulation during the teeth whitening procedure. The whitening formulation is supplied in three single use pens. The device is fitted with blue and red LED lights to simultaneously help enhance the bleaching procedure and protect the gums and soft tissues. FDA UDI

Identifiers

Primary DI / UDI-DI: 00353238006208 FDA UDI
FDA Product Code: EHY FDA UDI
MAU FDA UDI
GMDN Term: Teeth whitening kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6880 FDA UDI
872.6855 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Teeth whitening kit

Perio Sciences LED Tooth Whitener by Perio Sciences, LLC — 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: Perio Sciences, LLC

Sources (1)

FDA UDI 5a84b9e2-46ad-488d-8208-5f48c11a0e39 33 fields · synced May 30, 2026