AdDent 620007

GUDID D86962000706

The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening.

ADDENT, INC.

Fibreoptic dental light

• Primary Device ID: D86962000706
• NIH Device Record Key: 62175719-d1dc-4b98-802a-c97be580d7da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdDent
• Version Model Number: Microlux
• Catalog Number: 620007
• 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	D86962000706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062961

FDA Product Code

• NTK: Caries Detector, Laser Light, Transmission

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-01

On-Brand Devices [AdDent]

• D86962000706: The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps
• 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.