| Primary Device ID | D9499000312 |
| NIH Device Record Key | 3a481461-0ac9-45a5-a934-bcf0de6b98fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sales Rep/Virtual Demo Kit |
| Version Model Number | Sales Rep/Virtual Demo Kit |
| 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 | D9499000312 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
Moist Heat or Steam Sterilization
[D9499000312]
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 |
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| D9498271412 - Bioclear Evolve Posterior Kit | 2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations. |
| D949208011R1 - Bioclear TwinRing | 2023-09-25 Separator ring used in dental restorations. |
| D949208021R1 - Bioclear TwinRing | 2023-09-25 Separator ring used in dental restorations. |