Regennex-Etchant / Cleanser

GUDID 10818207020557

Vista Dental

Dentine bonding agent/set

• Primary Device ID: 10818207020557
• NIH Device Record Key: 99ff8d1d-33cf-43c7-b9ed-272b7a1e90b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regennex-Etchant / Cleanser
• Version Model Number: 90719-2
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061981

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2021-02-08
• Device Publish Date: 2021-01-29

Devices Manufactured by Vista Dental

• 10818207024876 - REGEN Bioactive EndoSealer (SS MST Kit): 2024-02-12
• 10818207024838 - Vista MST Visco Tip SS 17mm 50/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