| Primary Device ID | D9498270513 |
| NIH Device Record Key | bb7a4b6a-97ba-4546-858c-a6f126c327d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioclear Evolve Posterior Kit |
| Version Model Number | Complete |
| 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 | D9498270513 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
[D9498270513]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-19 |
| Device Publish Date | 2023-09-11 |
| D9498271212 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498270822 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498270612 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498270512 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498270613 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498270513 | Convenience kit of Bioclear products used in posterior dental restorations. |
| D9498271412 | Convenience kit of Bioclear products used in posterior dental restorations. |