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 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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