| Primary Device ID | 00810126506818 |
| NIH Device Record Key | 16ea155f-f1f9-4082-b123-c8d7828fdd24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visionary by 3D Dental |
| Version Model Number | XBAP0S |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810126506818 [Primary] |
| EGZ | Holder, Film, X-Ray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-13 |
| Device Publish Date | 2026-03-05 |
| 00817169023302 | Lead Apron Child Beige w/Collar |
| 00817169023296 | Lead Apron Child Blue w/Collar |
| 00817169023289 | Lead Apron Child Mauve w/Collar |
| 00817169023210 | Lead Apron Adult W/Collar Blue |
| 00817169023203 | Lead Apron Adult W/Collar Dark Red |
| 00817169023197 | Lead Apron Adult W/Collar Grey |
| 00817169023180 | Lead Apron Adult W/Collar Mauve |
| 00817169023173 | Lead Apron Adult W/Collar Surf Green |
| 00817169023166 | Lead Apron Adult W/Collar Tangerine |
| 00817169023159 | Lead Apron Panoramic Poncho Beige |
| 00817169023142 | Lead Apron Panoramic Poncho Mauve |
| 00817169023135 | Lead Free X-Ray Apron Adult W/Collar Blue |
| 00817169023128 | Lead Free X-Ray Apron Adult W/Collar Grey |
| 00817169023111 | Lead Free X-Ray Apron Adult W/Collar Lilac |
| 00817169023104 | Lead Free X-Ray Apron Adult W/Collar Mauve |
| 00817169023098 | Lead Free Panoramic Apron, Poncho Blue |
| 00817169023050 | Lead Apron Panoramic Poncho Blue |
| 00817169023586 | Phosphor Imaging Plates compatible AT - Type #0 |
| 00817169029380 | X-Ray Apron Hanger |
| 00817169029335 | Bitewing Arm Red |
| 00810126506801 | Visionary Bite Wing Tabs, Box/500 |
| 00810126506825 | Visionary premium barrier opt style envelope #1 250/bx with extended tab pre-loaded with cardb |
| 00810126506818 | Visionary premium barrier opt style envelope #0 250/bx with extended tab pre-loaded with cardb |
| 00810126506092 | Visionary premium barrier opt style envelope #2 250/bx with extended tab pre-loaded with cardb |