ZrC Syringe Kit

GUDID 00818207020987

Vista Dental

Dental restoration fixation cleaning solution
Primary Device ID00818207020987
NIH Device Record Key6c311879-8193-4d61-8e00-75876a6a4c4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZrC Syringe Kit
Version Model Number90782
Company DUNS036623932
Company NameVista Dental
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

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
GS100818207020987 [Direct Marking]
GS110818207020984 [Primary]

FDA Product Code

PMEExternal Cleaning Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-17
Device Publish Date2022-01-07

Devices Manufactured by Vista Dental

10818207024913 - RE-GEN Bioactive EndoPutty Kit2024-11-22
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

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