FUSION-DOE Light System 7700512

GUDID 00860179001075

FUSION-DOE Light System

Dentlight Inc.

Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light

• Primary Device ID: 00860179001075
• NIH Device Record Key: c0f4946a-576c-4e2e-a867-6b1c2935c6e2
• Commercial Distribution Discontinuation: 2021-08-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FUSION-DOE Light System
• Version Model Number: 7700512
• Catalog Number: 7700512
• Company DUNS: 171208585
• Company Name: Dentlight 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com
• Phone: 8007636901
• Email: sales1@dentlight.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860179001075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101140

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-17
• Device Publish Date: 2021-08-09

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• 00860179001037 - FUSION Plus Curing Light: 2021-08-17 FUSION Plus Curing Light
• 00860179001068 - FUSION Grand Curing Light: 2021-08-17 FUSION Grand Curing Light
• 00860179001075 - FUSION-DOE Light System: 2021-08-17FUSION-DOE Light System
• 00860179001075 - FUSION-DOE Light System: 2021-08-17 FUSION-DOE Light System
• 00860179001099 - iZoom Loupes: 2021-08-17 iZoom Magnification Loupes