| Primary Device ID | 00817169020721 |
| NIH Device Record Key | 540df591-8724-419d-9976-3dfab2b02a89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental - Joy |
| Version Model Number | JFN-SB1 |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, 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 | 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 |
| Storage Environment Temperature | Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817169020721 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-27 |
| Device Publish Date | 2016-12-14 |
| 00810126503169 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #25 |
| 00810126503176 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #30 |
| 00810126503213 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #50 |
| 00810126503220 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #60 |
| 00810126503237 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #70 |
| 00810126503244 - 3D Endo | 2025-12-24 Gutta Percha Points Box/60/Tapered .04 #80 |
| 00810126503251 - 3D Endo | 2025-12-24 Gutta Percha .06 Taper 60/Pk #15-40 |
| 00810126503305 - 3D Dental | 2025-12-24 Matrix Bands .001 Ultra Thin #1 12/Pk |