Verisplint OS

GUDID D040711740

Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

WHIP-MIX CORPORATION

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• Primary Device ID: D040711740
• NIH Device Record Key: e1bbd852-6fac-4523-aaba-b725c8eee569
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verisplint OS
• Version Model Number: 71174
• Company DUNS: 006385173
• Company Name: WHIP-MIX CORPORATION
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D040711740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190107

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2023-11-06
• Device Publish Date: 2023-10-27

On-Brand Devices [Verisplint OS]

• D040711471: Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used
• D040711740: Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used