Primary Device ID | D9492080110 |
NIH Device Record Key | f11449d9-2d2a-45cf-8081-4fdb2a015cc0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bioclear TwinRing |
Version Model Number | Molar |
Company DUNS | 059020838 |
Company Name | Bioclear Matrix Systems |
Device Count | 2 |
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 | false |
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 | D9492080110 [Unit of Use] |
HIBCC | D94920801121 [Primary] |
HIBCC | D94920801123 [Primary] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
[D9492080110]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-18 |
Device Publish Date | 2023-08-10 |
D9492080210 | Separator ring used in dental restorations. |
D9492080110 | Separator ring used in dental restorations. |
D9492080421 | Separator ring used in dental restorations. |
D9492080420 | Separator ring used in dental restorations. |
D949208021R1 | Separator ring used in dental restorations. |
D949208011R1 | Separator ring used in dental restorations. |