ScanDAR

GUDID D989SD11

Addition-curing silicone for Scanning Detection And bite Registration, extra hard, fast drying

Instarisa Technologies, LLC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: D989SD11
• NIH Device Record Key: 56df11c3-e6df-4444-9976-cc17f1892473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanDAR
• Version Model Number: SD1
• Company DUNS: 101879683
• Company Name: Instarisa Technologies, LLC
• 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: 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
HIBCC	D989SD11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051535

FDA Product Code

• ELW: Material, Impression

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: 2021-03-09
• Device Publish Date: 2021-03-01