Vista-Cal 2 pack Foil Pouch

GUDID 00818207020208

12.5 pH aqueous solution for temporary filling and cleansing root canals.

Vista Dental

Dental etching solution

• Primary Device ID: 00818207020208
• NIH Device Record Key: 56049088-346e-4769-a999-2222e83b33f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista-Cal 2 pack Foil Pouch
• Version Model Number: 3267
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 2
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818207020208 [Primary]
GS1	30818207020209 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963922

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: 2018-09-28
• Device Publish Date: 2018-08-28

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