Primary Device ID | D9498180812 |
NIH Device Record Key | 66701536-f017-4d3e-82c6-64b5d6e8a000 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biofit HD Posterior Kit |
Version Model Number | Complete |
Company DUNS | 059020838 |
Company Name | Bioclear Matrix Systems |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | D9498180812 [Primary] |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
[D9498180812]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2023-09-10 |
D9498180812 | Convenience kit of Bioclear products used in posterior dental restorations. |
D9498180032 | Convenience kit of Bioclear products used in posterior dental restorations. |
D9498180022 | Convenience kit of Bioclear products used in posterior dental restorations. |
D9498180012 | Convenience kit of Bioclear products used in posterior dental restorations. |