| Primary Device ID | 00817441020999 |
| NIH Device Record Key | 87481d41-a583-4672-89ef-ebd57d71dbd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prime Dent Visible Light Cure Micro Hybrid Composite |
| Version Model Number | 001-414 |
| Company DUNS | 027480775 |
| Company Name | PRIME DENTAL |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817441020999 [Primary] |
| 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 | 2017-01-04 |
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| 00817441020029 - Prime Dent Visible Light Cure Nano Hybrid Composite | 2019-11-14 Restorative Composite |
| 00817441022269 - Prime-Crown | 2019-11-14 temporary Crown material |
| 00817441020005 - Prime-Dent Visible Light Cure Nano-Hybrid Composite | 2018-07-06 Visible Light Cure Nano-Hybrid Composite |
| 00817441023556 - Prime-Core Chemical Cure Core Build Up | 2018-07-06 Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE |