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FUSION-DOE Light System

FDA UDI

Class II (US FDA UDI)

by Dentlight Inc.

Identity

Trade Name
FUSION-DOE Light System FDA UDI
Generic Name
Oral lesion examination light FDA UDI
Device Name
FUSION-DOE Light System FDA UDI
Model / Reference
7700512 FDA UDI
Description
FUSION-DOE Light System FDA UDI

Identifiers

Catalog Number
7700512 FDA UDI
Primary DI / UDI-DI
00860179001075 FDA UDI
510(k) Number
K101140 FDA UDI
FDA Product Code
NXV FDA UDI
GMDN Term
Oral lesion examination light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oral lesion examination light

FUSION-DOE Light System by Dentlight Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral lesion examination light.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentlight Inc.

Sources (1)

  • FDA UDI c0f4946a-576c-4e2e-a867-6b1c2935c6e2 37 fields · synced May 29, 2026