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AdDent

FDA UDI

Class II (US FDA UDI)

by Addent, Inc.

Identity

Trade Name
AdDent FDA UDI
Generic Name
Oral lesion examination light FDA UDI
Device Name
The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities. FDA UDI
Model / Reference
Bio/Screen FDA UDI
Description
The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities. FDA UDI

Identifiers

Catalog Number
110090 FDA UDI
Primary DI / UDI-DI
D86911009002 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

AdDent by Addent, 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
Addent, Inc.

Sources (1)

  • FDA UDI 18bda460-8b2c-4a73-8a80-44bb42688abe 35 fields · synced May 30, 2026