Primary Device ID | E27666979860 |
NIH Device Record Key | 9a328902-0ea9-403e-b2f3-4cf0bb96886f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CEREC Ortho Software |
Version Model Number | 6697986 |
Company DUNS | 340306351 |
Company Name | SIRONA Dental Systems GmbH |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E27666979860 [Primary] |
PNN | Orthodontic Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-25 |
Device Publish Date | 2019-09-17 |
E27666979860 | CEREC Ortho Software Version 2.0.0 |
E27666111690 | CEREC Ortho Software Version 1.2.0 |
E27667483590 | CEREC Ortho Software Version 2.1 |
E27667844950 | CEREC Ortho Software Version 2.1 Upgrade |