Primary Device ID | D9493020110 |
NIH Device Record Key | e55ac897-cd9d-48d1-bef5-90b709a205b8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Original Anterior Matrix DC Series |
Version Model Number | DC201 |
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 | D9493020110 [Unit of Use] |
HIBCC | D949302011051 [Primary] |
HIBCC | D949302011101 [Primary] |
HIBCC | D949302011151 [Primary] |
HIBCC | D949302011251 [Primary] |
HIBCC | D949302011501 [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 |
D9493020410 | Clear matrix used in dental restorations. |
D9493020310 | Clear matrix used in dental restorations. |
D9493020210 | Clear matrix used in dental restorations. |
D9493020110 | Clear matrix used in dental restorations. |