AdDent 110090

GUDID D86911009002

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.

ADDENT, INC.

Oral lesion examination light

• Primary Device ID: D86911009002
• NIH Device Record Key: 18bda460-8b2c-4a73-8a80-44bb42688abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdDent
• Version Model Number: Bio/Screen
• Catalog Number: 110090
• Company DUNS: 099490679
• Company Name: ADDENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2037780200
• Email: dpinto@addent.com
• Phone: 2037780200
• Email: dpinto@addent.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D86911009002 [Primary]

FDA Product Code

• NXV: Diagnostic Light, Soft Tissue Detector

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-01

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• D8691120010: The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a
• D86911009002: The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral ex
• D86911008001: The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also hel
• D8691100000: Calset warmer for composite materials/anaesthesia and instruments.