Primary Device ID | E23532800 |
NIH Device Record Key | 5a579480-7154-4c11-9fd9-20033479522b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HY-Bond Resiglass |
Version Model Number | 3280 |
Catalog Number | 3280 |
Company DUNS | 054618202 |
Company Name | SHOFU DENTAL CORPORATION |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 760-566-3528 |
ckaemmerlen@shofu.com |
Handling Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E23532800 [Primary] |
HIBCC | E235328001 [Unit of Use] |
EMA | Cement, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
E235P08111 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-1 5pcs |
E235P08121 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-2 5pcs |
E235P08131 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-A1 5pcs |
E235P08141 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-A2 5pcs |
E235P08151 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-BL3 5pcs |
E235P08161 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g E-BL4 5pcs |
E235P08201 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g HT-A1 5pcs |
E235P08211 - VINTAGE PRIME PRESS | 2024-04-12 VINTAGE PRIME PRESS 3g HT-A2 5pcs |