| Primary Device ID | D9493190110 |
| NIH Device Record Key | ab2dcc1a-08aa-4851-9559-8b1a917c8ce0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HD Anterior Matrix DC Series |
| Version Model Number | DC201 HD |
| 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 | D9493190110 [Unit of Use] |
| HIBCC | D949319011051 [Primary] |
| HIBCC | D949319011101 [Primary] |
| HIBCC | D949319011151 [Primary] |
| HIBCC | D949319011251 [Primary] |
| HIBCC | D949319011253 [Primary] |
| HIBCC | D949319011501 [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 | 2023-09-18 |
| Device Publish Date | 2023-09-10 |
| D9493190310 | Clear matrix used in dental restorations. |
| D94931903109 | Clear matrix used in dental restorations. |
| D9493190210 | Clear matrix used in dental restorations. |
| D94931902109 | Clear matrix used in dental restorations. |
| D9493190110 | Clear matrix used in dental restorations. |
| D94931901109 | Clear matrix used in dental restorations. |