PinkWave Kit

GUDID 10818207020656

Vista Dental

Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp

Primary Device ID	10818207020656
NIH Device Record Key	fbcb26d1-abfc-4f40-96b0-3074eeb43d8e
Commercial Distribution Status	In Commercial Distribution
Brand Name	PinkWave Kit
Version Model Number	90734
Company DUNS	036623932
Company Name	Vista Dental
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

Customer Support Contacts

Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com
Phone	262-636-9755
Email	info@vista-dental.com

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0.5 KiloPascal and 1.4 KiloPascal
Handling Environment Atmospheric Pressure	Between 0.697 KiloPascal and 1.013 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170101

FDA Product Code

EBZ	Activator, Ultraviolet, For Polymerization