iZoom Loupes 8500051

GUDID 00860179001099

iZoom Magnification Loupes

Dentlight Inc.

Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe Loupe

• Primary Device ID: 00860179001099
• NIH Device Record Key: 5ba90af6-3bfe-4631-b957-69690b715bd9
• Commercial Distribution Discontinuation: 2021-08-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iZoom Loupes
• Version Model Number: 8500051
• Catalog Number: 8500051
• Company DUNS: 171208585
• Company Name: Dentlight Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860179001099 [Primary]

FDA Product Code

• FSP: Loupe, Diagnostic/Surgical

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

Devices Manufactured by Dentlight Inc.

• 00860179001044 - Ultrafast Diode Laser: 2022-02-01 Ultrafast Diode Laser
• 00860179001006 - FUSION Curing Light: 2021-08-17 FUSION Curing Light
• 00860179001020 - Nano Freedom Headlight: 2021-08-17 Nano Freedom Headlight
• 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: 2021-08-17 FUSION-DOE Light System
• 00860179001099 - iZoom Loupes: 2021-08-17iZoom Magnification Loupes
• 00860179001099 - iZoom Loupes: 2021-08-17 iZoom Magnification Loupes