SmartByte Palatal Impression Kit

GUDID 00860001615319

Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower teeth

SCIENTIFIC INTAKE LIMITED CO.

Dental impression material kit, single-use

• Primary Device ID: 00860001615319
• NIH Device Record Key: f0d25913-6c63-4fe0-8302-a18ed28104b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartByte Palatal Impression Kit
• Version Model Number: SI-004.01
• Company DUNS: 827444881
• Company Name: SCIENTIFIC INTAKE LIMITED CO.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00860001615319 [Primary]

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: 2019-05-31
• Device Publish Date: 2019-05-23

Devices Manufactured by SCIENTIFIC INTAKE LIMITED CO.

• 00860001615319 - SmartByte Palatal Impression Kit: 2019-05-31Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower teeth
• 00860001615319 - SmartByte Palatal Impression Kit: 2019-05-31 Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower
• 00860001615326 - SmartByte Device: 2019-05-31 Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.