| Primary Device ID | D9498271712 |
| NIH Device Record Key | e241b52b-5158-4201-a3fb-fd9dfa91534a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evolve All-in-One Select Kit |
| Version Model Number | Full |
| Company DUNS | 059020838 |
| Company Name | Bioclear Matrix Systems |
| 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 | false |
| 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 |
|---|---|
| HIBCC | D9498271712 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
[D9498271712]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-11 |
| Device Publish Date | 2024-12-03 |
| D9498271612 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498271712 | Convenience kit of Bioclear products used in posterior dental restorations. |