Primary Device ID | 04560128312585 |
NIH Device Record Key | dd5c20c1-26ab-40a1-b5af-7367f58bf81b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dentalis |
Version Model Number | Set |
Company DUNS | 691229181 |
Company Name | NEO DENTAL CHEMICAL PRODUCTS CO.,LTD. |
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 | 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 | 253-946-0814 |
karin@neodental-intl.com |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04560128312585 [Primary] |
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 | 2016-12-05 |
04560128312608 | Endodontic sealing material, 10mL Liquid |
04560128312592 | Endodontic sealing material, 15g Powder |
04560128312585 | Endodontic sealing material, 15g Powder, 10mL Liquid |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DENTALIS 75016230 2203094 Live/Registered |
Neo Dental Chemical Products Co., LTD 1995-10-30 |