Vista-Cal Refill Kit

GUDID 20818207020202

12.5 pH aqueous solution for temporary filling and cleansing root canals. Refill kit includes (20) 1.2mL prefilled high pressure syringes.

Vista Dental

Dental etching solution

• Primary Device ID: 20818207020202
• NIH Device Record Key: ddfc5d9e-c10e-4e10-84ee-e4fd51533349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista-Cal Refill Kit
• Version Model Number: 502601
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	20818207020202 [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: 2018-08-31
• Device Publish Date: 2018-07-31

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• 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