Glidewell™ 3DP Denture Teeth Resin Shade BL1 70-1164-GBD0011

GUDID D745701164GBD00110

Glidewell™ 3DP Denture Teeth Resin Shade BL1

Prismatik Dentalcraft, Inc

Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth

• Primary Device ID: D745701164GBD00110
• NIH Device Record Key: 43144b56-1836-4071-8f73-9b1d26378698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glidewell™ 3DP Denture Teeth Resin Shade BL1
• Version Model Number: 70-1164-GBD0011
• Catalog Number: 70-1164-GBD0011
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	D745701164GBD00110 [Primary]

FDA Product Code

• PZY: Additively manufactured, preformed, resin denture tooth

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: 2023-12-12
• Device Publish Date: 2023-12-04

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