Dentivera

GUDID 00842326104396

Ultaire AKP Dentivera 18mm disc, white

The Myerson Company Limited

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 00842326104396
• NIH Device Record Key: 4214b4a0-6ce8-4d44-b8da-d653a54b4c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentivera
• Version Model Number: UD-W-9818
• 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
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326104396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160498

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [Dentivera]

• 00842326104426: Ultaire AKP Dentivera 24mm disc, tan
• 00842326104419: Ultaire AKP Dentivera 24mm disc, white
• 00842326104402: Ultaire AKP Dentivera 18mm disc, tan
• 00842326104396: Ultaire AKP Dentivera 18mm disc, white