| Primary Device ID | D9493010110 |
| NIH Device Record Key | 97112860-7d1a-4c9e-8181-b9ba149634a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Original Anterior Matrix A Series |
| Version Model Number | A101 |
| Company DUNS | 059020838 |
| Company Name | Bioclear Matrix Systems |
| Device Count | 50 |
| 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 | 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 | D9493010110 [Unit of Use] |
| HIBCC | D949301011101 [Primary] |
| HIBCC | D949301011151 [Primary] |
| HIBCC | D949301011251 [Primary] |
| HIBCC | D949301011501 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-21 |
| Device Publish Date | 2023-08-11 |
| D9493010110 | Clear matrix used in dental restorations. |
| D949301021101 | Clear matrix used in dental restorations. |
| D9493010510 | Clear matrix used in dental restorations. |
| D9493010410 | Clear matrix used in dental restorations. |
| D9493010310 | Clear matrix used in dental restorations. |
| D9493010210 | Clear matrix used in dental restorations. |