| Primary Device ID | 00810120870762 |
| NIH Device Record Key | 257cb229-2f88-4736-8dc8-81e498a02fef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acero Crowns ES |
| Version Model Number | ES U5 |
| Company DUNS | 006672536 |
| Company Name | Park - Istre, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00810120870762 [Primary] |
| ELZ | Crown, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-07 |
| Device Publish Date | 2022-10-30 |
| 00810120870779 | ES U6 |
| 00810120870762 | ES U5 |
| 00810120870755 | ES U4 |
| 00810120870748 | ES U3 |
| 00810120870731 | ES U2 |
| 00810120870724 | ES U1 |
| 00810120870717 | ES G6 |
| 00810120870700 | ES G5 |
| 00810120870694 | ES G4 |
| 00810120870687 | ES G3 |
| 00810120870670 | ES G2 |
| 00810120870663 | ES G1 |
| 00810120870656 | ES F6 |
| 00810120870649 | ES F5 |
| 00810120870632 | ES F4 |
| 00810120870625 | ES F3 |
| 00810120870618 | ES F2 |
| 00810120870601 | ES F1 |
| 00810120870595 | ES E6 |
| 00810120870588 | ES E5 |
| 00810120870571 | ES E4 |
| 00810120870564 | ES E3 |
| 00810120870557 | ES E2 |
| 00810120870540 | ES E1 |
| 00810120870533 | ES D6 |
| 00810120870526 | ES D5 |
| 00810120870519 | ES D4 |
| 00810120870502 | ES D3 |
| 00810120870496 | ES D2 |
| 00810120870489 | ES D1 |