Exquisite Restoration Unit Dose Sample Pack (5 per Pack) - B1 Shade

GUDID 00818207020376

Vista Dental

Dental composite resin
Primary Device ID00818207020376
NIH Device Record Keya58825a6-8f90-45bc-9ada-b6b6c81f21b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameExquisite Restoration Unit Dose Sample Pack (5 per Pack) - B1 Shade
Version Model Number90583
Company DUNS036623932
Company NameVista Dental
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com
Phone2626339755
Emailinfo@vista-dental.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818207020376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-29

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