AlliedStar 6583169
GUDID 06973993442017
AS 100 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
Intraoral optical scanning system| Primary Device ID | 06973993442017 |
| NIH Device Record Key | 66141e4f-3d2c-4a58-89ae-e8655409a2cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AlliedStar |
| Version Model Number | AS 100 |
| Catalog Number | 6583169 |
| Company DUNS | 703541803 |
| Company Name | Alliedstar Medical Equipment Co., Ltd. |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973993442017 [Primary] |
FDA Product Code
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
[06973993442017]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-28 |
| Device Publish Date | 2022-09-20 |
On-Brand Devices [AlliedStar]
| 06973993442017 | AS 100 Intraoral Scanner |
| 06973993442048 | AS 260 |
| 06973993440051 | AS 260 Handpiece |
Trademark Results [AlliedStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLIEDSTAR 98749037 not registered Live/Pending |
Alliedstar Medical Equipment Co.,Ltd. 2024-09-13 |
 ALLIEDSTAR 90601634 not registered Live/Pending |
Alliedstar Medical Equipment Co., Ltd. 2021-03-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.