Visiclear

GUDID 00842326102507

12.5kg Thermoplastic Resin Material

The Myerson Company Limited

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 00842326102507
• NIH Device Record Key: 192eb185-4a8b-4eb8-b89f-b57c46cd36af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visiclear
• Version Model Number: VC-12.5kg
• Company DUNS: 857278431
• Company Name: The Myerson Company Limited
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 18004232683
• Email: orders@myersontooth.com

Device Dimensions

• Weight: 12.5 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326102507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063626

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2016-09-24

On-Brand Devices [Visiclear]

• 00842326104242: Clear Disc, 98mm x 20mm Bulk Package
• 00842326104235: Clear Disc, 98mm x 15mm Bulk Package
• 00842326104181: Clear Disc, 98mm x 25mm
• 00842326104174: Clear Disc, 98mm x 20mm
• 00842326104167: Clear Disc, 98mm x 15mm
• 00842326102569: Single Shot 6pk Thermoplastic Resin Material
• 00842326102545: Medium cartridges 6pk Thermoplastic Resin Material
• 00842326102538: Small cartridges 6pk Thermoplastic Resin Material
• 00842326102521: Large cartridges 6pk Thermoplastic Resin Material
• 00842326102514: 400g Jar Thermoplastic Resin Material
• 00842326102507: 12.5kg Thermoplastic Resin Material