Primary Device ID | D949304031C0 |
NIH Device Record Key | d945aa4b-fdac-42c7-920b-ee515dea7b32 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Original Posterior Matrix M Series |
Version Model Number | M403 Clear |
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 | D94930403125C1 [Primary] |
HIBCC | D94930403150C1 [Primary] |
HIBCC | D949304031C0 [Unit of Use] |
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 | 2023-09-19 |
Device Publish Date | 2023-09-11 |
D949304061C0 | Clear matrix used in dental restorations. |
D949304061B0 | Clear matrix used in dental restorations. |
D949304051C0 | Clear matrix used in dental restorations. |
D949304051B0 | Clear matrix used in dental restorations. |
D949304041C0 | Clear matrix used in dental restorations. |
D949304041B0 | Clear matrix used in dental restorations. |
D949304031C0 | Clear matrix used in dental restorations. |
D949304031B0 | Clear matrix used in dental restorations. |
D949304021C0 | Clear matrix used in dental restorations. |
D949304021B0 | Clear matrix used in dental restorations. |
D949304011C0 | Clear matrix used in dental restorations. |
D949304011B0 | Clear matrix used in dental restorations. |