Primary Device ID | D9498270822 |
NIH Device Record Key | e42c362b-7c17-44f0-82a6-00ae0fbbd8a2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bioclear Evolve Posterior Kit |
Version Model Number | Pink Add-On 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 | true |
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 | D9498270822 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2023-09-10 |
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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. |