AlliedStar 6583169

GUDID 06973993442017

AS 100 Intraoral Scanner

Alliedstar Medical Equipment Co., Ltd.

Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system 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