RE-GEN Bioactive EndoSealer

GUDID 20818207023180

Vista Dental

Root canal obturation kit

• Primary Device ID: 20818207023180
• NIH Device Record Key: 7991a730-60c5-4dfd-8a8b-6a8fd35fd394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RE-GEN Bioactive EndoSealer
• Version Model Number: 504753
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com
• Phone: 262-633-9755
• Email: info@vista-dental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207023183 [Primary]
GS1	20818207023180 [Package]; Contains: 10818207023183; Package: Case [20 Units]; In Commercial Distribution
GS1	30818207023187 [Package]; Contains: 10818207023183; Package: Sample [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221811

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-10
• Device Publish Date: 2023-05-02

Devices Manufactured by Vista Dental

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