| Primary Device ID | 00817169021308 |
| NIH Device Record Key | c4bafa9e-2689-4f70-9c2a-b9da77bda0a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plasmaid-3D Dental |
| Version Model Number | ENSP |
| 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 | 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 |
| Phone | 877 605 8061 |
| cs@3d-dent.com | |
| Phone | 877 605 8061 |
| cs@3d-dent.com | |
| Phone | 877 605 8061 |
| cs@3d-dent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817169021308 [Primary] |
| EAT | Tester, Pulp |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-19 |
| 00817169023418 - 3D Green by 3D Dental | 2024-07-25 Syringe Sleeves Biodegradable 2.5"x10" Box (500) |
| 00817169023425 - 3D Green by 3D Dental | 2024-07-25 Headrest Covers Biodegradable 10"x11" Box (250) |
| 00817169023432 - 3D Green by 3D Dental | 2024-07-25 Headrest Covers Biodegradable 10"x14" Box (250). |
| 00817169023449 - 3D Green by 3D Dental | 2024-07-25 Chair Sleeves Half Biodegradable 27.5"x24" Roll (225) |
| 00817169023456 - 3D Green by 3D Dental | 2024-07-25 Bite Clock Covers Biodegradable (1000) |
| 00817169024651 - Essentials by 3D Dental | 2024-07-25 Headrest Cover Paper/Poly 10x13 Blue 500/Cs |
| 00817169024668 - Essentials by 3D Dental | 2024-07-25 Headrest Cover Paper/Poly 10x10 White 500/Cs |
| 00817169024675 - Essentials by 3D Dental | 2024-07-25 Headrest Cover Paper/Poly 10x13 White 500/Cs |