| Primary Device ID | 00817169021322 |
| NIH Device Record Key | 10831210-a518-439c-a793-bcb25a0b83fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Joy-3D Dental |
| Version Model Number | JAF-2 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817169021322 [Primary] |
| EJJ | Alloy, Amalgam |
| 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 | 2017-07-13 |
| 00817169021360 | JOY-ALLOY 3 SPILL REGULAR SET JAR/50 |
| 00817169021353 | JOY-ALLOY 2 SPILL REGULAR SET JAR/50 |
| 00817169021346 | JOY-ALLOY 1 SPILL REGULAR SET JAR/50 |
| 00817169021339 | JOY-ALLOY 3 SPILL FAST SET JAR/50 |
| 00817169021322 | JOY-ALLOY 2 SPILL FAST SET JAR/50 |
| 00817169021315 | JOY-ALLOY 1 SPILL FAST SET JAR/50 |
| 00817169020455 | JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A1 |