| Primary Device ID | 00817169028697 |
| NIH Device Record Key | a78de5c8-9a7f-471c-8e57-c3629f4e5d06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evolve by 3D Dental |
| Version Model Number | EVACUL4 |
| Catalog Number | EVACUL4 |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, 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 | 00817169028697 [Primary] |
| ELZ | Crown, Preformed |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
[00817169028697]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-11-17 |
| Device Publish Date | 2022-12-28 |
| 00817169028208 | Evolve Stainless Steel Primary Molar Crowns 1st Upper Left-4 Box Of 5 |
| 00817169028895 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #6 Crowns Box Of 5 |
| 00817169028888 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #5 Crowns Box Of 5 |
| 00817169028871 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #4 Crowns Box Of 5 |
| 00817169028864 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #3 Crowns Box |
| 00817169028857 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #2 Crowns Box |
| 00817169028840 | Evolve Stainless Steel Primary Anterior Lateral Upper Right #1 Crowns Box |
| 00817169028833 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #6 Crowns Box Of 5 |
| 00817169028826 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #5 Crowns Box Of 5 |
| 00817169028819 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #4 Crowns Box Of 5 |
| 00817169028802 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #3 Crowns Box |
| 00817169028796 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #2 Crowns Box |
| 00817169028789 | Evolve Stainless Steel Primary Anterior Lateral Upper Left #1 Crowns Box |
| 00817169028772 | Evolve Stainless Steel Primary Anterior Central Upper Right #6 Crowns Box |
| 00817169028765 | Evolve Stainless Steel Primary Anterior Central Upper Right #5 Crowns Box |
| 00817169028758 | Evolve Stainless Steel Primary Anterior Central Upper Right #4 Crowns Box |
| 00817169028741 | Evolve Stainless Steel Primary Anterior Central Upper Right #3 Crowns Box |
| 00817169028734 | Evolve Stainless Steel Primary Anterior Central Upper Right #2 Crowns Box |
| 00817169028727 | Evolve Stainless Steel Primary Anterior Central Upper Right #1 Crowns Box |
| 00817169028710 | Evolve Stainless Steel Primary Anterior Central Upper Left #6 Crowns Box |
| 00817169028703 | Evolve Stainless Steel Primary Anterior Central Upper Left #5 Crowns Box |
| 00817169028697 | Evolve Stainless Steel Primary Anterior Central Upper Left #4 Crowns Box |
| 00817169028680 | Evolve Stainless Steel Primary Anterior Central Upper Left #3 Crowns Box |
| 00817169028673 | Evolve Stainless Steel Primary Anterior Central Upper Left #2 Crowns Box |
| 00817169028666 | Evolve Stainless Steel Primary Anterior Central Upper Left #1 Crowns Box... |
| 00817169028659 | Evolve Stainless Steel Primary Anterior Cuspid Upper #6 Crowns Box Of 5 |
| 00817169028642 | Evolve Stainless Steel Primary Anterior Cuspid Upper #5 Crowns Box Of 5 |
| 00817169028635 | Evolve Stainless Steel Primary Anterior Cuspid Upper #4 Crowns Box Of 5 |
| 00817169028628 | Evolve Stainless Steel Primary Anterior Cuspid Upper #3 Crowns Box Of 5 |
| 00817169028611 | Evolve Stainless Steel Primary Anterior Cuspid Upper #2 Crowns Box Of 5 |
| 00817169028604 | Evolve Stainless Steel Primary Anterior Cuspid Upper #1 Crowns Box Of 5 |
| 00817169028598 | Evolve Stainless Steel Primary Anterior Cuspid Lower#6 Crowns Box Of 5 |
| 00817169028581 | Evolve Stainless Steel Primary Anterior Cuspid Lower#5 Crowns Box Of 5 |
| 00817169028574 | Evolve Stainless Steel Primary Anterior Cuspid Lower#4 Crowns Box Of 5 |
| 00817169028567 | Evolve Stainless Steel Primary Anterior Cuspid Lower#3 Crowns Box Of 5 |
| 00817169028550 | Evolve Stainless Steel Primary Anterior Cuspid Lower#2 Crowns Box Of 5 |
| 00817169028543 | Evolve Stainless Steel Primary Anterior Cuspid Lower#1 Crowns Box Of 5 |
| 00817169028536 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-7 Box Of 5 |
| 00817169028529 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-6 Box Of 5 |
| 00817169028512 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-5 Box Of 5 |
| 00817169028505 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-4 Box Of 5 |
| 00817169028499 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-3 Box Of 5 |
| 00817169028482 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Right-2 Box Of 5 |
| 00817169028475 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-7 Box Of 5 |
| 00817169028468 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-6 Box Of 5 |
| 00817169028451 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-5 Box Of 5 |
| 00817169028444 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-4 Box Of 5 |
| 00817169028437 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-3 Box Of 5 |
| 00817169028420 | Evolve Stainless Steel Primary Molar Crowns 2nd Upper Left-2 Box Of 5 |
| 00817169028413 | Evolve Stainless Steel Primary Molar Crowns 2nd Lower Right-7 Box Of 5 |