ZrP Syringe Kit

GUDID 00818207020840

Vista Dental

Dental prosthesis-component adhesive
Primary Device ID00818207020840
NIH Device Record Keye038ecef-5c8c-43da-a938-c3b83c1e03f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameZrP Syringe Kit
Version Model Number90578
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

Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
Emailinfo@vista-dental.com
Phone262-636-9755
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100818207020840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, 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

Devices Manufactured by Vista Dental

10818207024876 - REGEN Bioactive EndoSealer (SS MST Kit)2024-02-12
10818207024838 - Vista MST Visco Tip SS 17mm 50/cup2023-10-10
10818207024845 - Vista MST Visco Tip SS 22mm 50/cup2023-10-10
10818207024852 - Vista MST Visco Tip SS 17mm 20/cup2023-10-10
10818207024869 - Vista MST Visco Tip SS 22mm 20/cup2023-10-10
10818207024333 - VacuSeal Syringe2023-06-19
10818207024340 - SmearOFF System (PS System)2023-06-19
10818207024357 - PS System - Chlor-Xtra Plus Bag (40mL)2023-06-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.