FUSION-DOE Light System 7700512

GUDID 00860179001075

FUSION-DOE Light System

Dentlight Inc.

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