| Primary Device ID | 00817169029205 |
| NIH Device Record Key | 1323ff76-4b28-4621-a9c4-aebf1a1a9b45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Joy by 3D Dental |
| Version Model Number | 1 |
| Catalog Number | JFB3 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817169029205 [Primary] |
| EBF | Material, tooth shade, resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-24 |
| Device Publish Date | 2025-12-16 |
| 00810126506177 | Joy Polishing Mandrel 3/Bg |
| 00810126506160 | Joy Polishing discs 14mm Super Fine Jar of 85 |
| 00810126506153 | Joy Polishing discs 14mm Medium Jar of 85 |
| 00810126506139 | Joy Polishing discs 14mm Coarse Jar of 85 |
| 00810126506122 | Joy Polishing discs 10mm Super Fine Jar of 85 |
| 00810126506115 | Joy Polishing discs 10mm Medium Jar of 85 |
| 00810126506108 | Joy Polishing discs 10mm Fine Jar of 85 |
| 00817169029410 | JOYFIL Flowable Composite Refill 2gm 4/Pk D4 |
| 00817169029403 | JOYFIL Flowable Composite Refill 2gm 4/Pk C3 |
| 00817169029212 | Flowable Composite Refill 2gm 4/Pk B4 |
| 00817169029205 | Flowable Composite Refill 2gm 4/Pk B3 |
| 00810126506146 | Joy Polishing discs 14mm Fine Jar of 85 |