Primary Device ID | D840DWOSCAD1 |
NIH Device Record Key | d8685a4b-3091-4de2-baa6-61c518f2b1f2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DWOS |
Version Model Number | 9 |
Company DUNS | 202983169 |
Company Name | Dental Wings Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
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 |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D840DWOSCAD1 [Primary] |
NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-19 |
Device Publish Date | 2019-04-11 |
D840DWIO1000 - Intraoral Scanner | 2019-04-19 |
D840DWOSCAD1 - DWOS | 2019-04-19Dental CADCAM Software |
D840DWOSCAD1 - DWOS | 2019-04-19 Dental CADCAM Software |
D840DWOSCS1 - DWOS Chairside | 2019-04-19 Dental CADCAM Software |
D840DW3900 - 3Series | 2019-04-12 |
D840DW71400 - 7Series | 2019-04-12 |
D840DWCIS1000 - iSeries | 2019-04-12 |
D840DWIO0010 - Intraoral Scanner | 2019-04-12 |
D840DWIO0100 - Intraoral Scanner | 2019-04-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DWOS 97797377 not registered Live/Pending |
Noble Drilling Services LLC 2023-02-16 |
![]() DWOS 87379612 5403643 Live/Registered |
Noble Drilling Services Inc. 2017-03-21 |
![]() DWOS 75683489 2368197 Dead/Cancelled |
Ericsson Inc. 1999-04-14 |