Primary Device ID | 17540208000384 |
NIH Device Record Key | 97e09edf-86f0-4e96-9de8-26634bbadb46 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Select Calcium Hydroxide Liner LC |
Version Model Number | CAL-LINER |
Catalog Number | CAL-LINER |
Company DUNS | 486717338 |
Company Name | Zendo Direct AG |
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 |
Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540208000387 [Primary] |
GS1 | 17540208000384 [Package] Contains: 07540208000387 Package: Carton [1 Units] In Commercial Distribution |
EJK | Liner, Cavity, Calcium Hydroxide |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-09-26 |
17540208000339 - Select Supratemp | 2018-05-07 Self cure temporary crown and bridge material - Shade: A3 |
17540208000131 - Select NanoFill | 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A2 |
17540208000254 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A1 |
17540208000261 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A2 |
17540208000278 - Select Flow | 2018-03-29 Light cure easy flowable microhybrid composite - Needle Tubes; Shade A3 |
17540208000308 - Select NanoFill | 2018-03-29 Low shrink low abrasion light cure nano filled composite - Caps; Shade A1 |
27540208000398 - MTA Capsules | 2018-03-29 Endodontic repair cement - Universal; 0.3 g capsules |
27540208000404 - MTA Firm- Normal Set | 2018-03-29 Endodontic repair cement - 0.25 g capsules |