AvaDent
GUDID D843GDS9834EA350
PMMA Puck, CAD-CAM denture base material
GLOBAL DENTAL SCIENCE LLC
Dental appliance fabrication material, thermoplastic| Primary Device ID | D843GDS9834EA350 |
| NIH Device Record Key | c333b424-7be3-402b-8a0e-83f12b50c149 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AvaDent |
| Version Model Number | PCK4603 |
| Company DUNS | 037170061 |
| Company Name | GLOBAL DENTAL SCIENCE LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 480-275-2736 |
| chuck.johnson@AvaDent.com | |
| Phone | 480-275-2736 |
| chuck.johnson@AvaDent.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D843GDS9834EA350 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153590
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 | 2018-08-23 |
| Device Publish Date | 2018-07-23 |
On-Brand Devices [AvaDent]
| D843GDS9836EOM30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836ED30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EC20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EC10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EB20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EB10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EA350 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EA30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EA20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836EA10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836AVO0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836AVL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836AVED0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836AVD0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9836AVCL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9835EA10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EOM30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834ED30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EC20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EC10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EB20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EB10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EA350 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EA30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EA20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834EA10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834AVO0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834AVL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834AVED0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834AVD0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9834AVCL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EOM30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832ED30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EC20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EC10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EB20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EB10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EA350 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EA30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EA20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832EA10 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832AVO0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832AVL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832AVED0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832AVD0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9832AVCL0 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9830EOM30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9830ED30 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9830EC20 | PMMA Puck, CAD-CAM denture base material |
| D843GDS9830EC10 | PMMA Puck, CAD-CAM denture base material |
Trademark Results [AvaDent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVADENT 86394604 4793349 Live/Registered |
GLOBAL DENTAL SCIENCE LLC 2014-09-15 |
 AVADENT 85968029 4475110 Live/Registered |
Global Dental Science LLC 2013-06-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.