| Primary Device ID | 00810120871073 |
| NIH Device Record Key | 2f8040f4-67e0-42c5-970b-1558ae955cb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acero Crowns ES - Light |
| Version Model Number | ESL U6 |
| 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 | 00810120871073 [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 |
| 00810120871073 | ESL U6 |
| 00810120871066 | ESL U5 |
| 00810120871059 | ESL U4 |
| 00810120871042 | ESL U3 |
| 00810120871035 | ESL U2 |
| 00810120871028 | ESL U1 |
| 00810120871011 | ESL G6 |
| 00810120871004 | ESL G5 |
| 00810120870991 | ESL G4 |
| 00810120870984 | ESL G3 |
| 00810120870977 | ESL G2 |
| 00810120870960 | ESL G1 |
| 00810120870953 | ESL F6 |
| 00810120870946 | ESL F5 |
| 00810120870939 | ESL F4 |
| 00810120870922 | ESL F3 |
| 00810120870915 | ESL F2 |
| 00810120870908 | ESL F1 |
| 00810120870892 | ESL E6 |
| 00810120870885 | ESL E5 |
| 00810120870878 | ESL E4 |
| 00810120870861 | ESL E3 |
| 00810120870854 | ESL E2 |
| 00810120870847 | ESL E1 |
| 00810120870830 | ESL D6 |
| 00810120870823 | ESL D5 |
| 00810120870816 | ESL D4 |
| 00810120870809 | ESL D3 |
| 00810120870793 | ESL D2 |
| 00810120870786 | ESL D1 |