Primary Device ID | D798SEPD0 |
NIH Device Record Key | 70768626-81aa-4dab-b7ae-c167de7ad387 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Self Etching Primer |
Version Model Number | SEPD |
Catalog Number | SEPD |
Company DUNS | 113170088 |
Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 630-773-4009 |
paulgropi@aol.com | |
Phone | 630-773-4009 |
paulgropi@aol.com |
Special Storage Condition, Specify | Between 0 and 0 *store in ambient conditions |
Special Storage Condition, Specify | Between 0 and 0 *store in ambient conditions |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D798SEPD0 [Primary] |
KLE | Agent, Tooth Bonding, Resin |
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 | 2016-08-01 |
D798SEPR0 | The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the pre |
D798SEPPRO0 | The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of |
D798SEPD0 | The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the deliver |
D798SEPC0 | The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of |