REGEN Bioactive EndoSealer (SS MST Kit)

GUDID 10818207024876

Vista Dental

Root canal obturation kit
Primary Device ID10818207024876
NIH Device Record Key5c52d9ff-78b3-4ce5-b3d1-a75bdd8711d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGEN Bioactive EndoSealer (SS MST Kit)
Version Model Number504754
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 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

Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
Emailinfo@vista-dental.com
Phone262-633-9755
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
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
GS110818207024876 [Primary]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-02

Devices Manufactured by Vista Dental

10818207024913 - RE-GEN Bioactive EndoPutty Kit2024-11-22
10818207024876 - REGEN Bioactive EndoSealer (SS MST Kit)2024-02-12
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

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