Glidewell™ 3DP Denture Teeth Resin Shade A4 70-1164-GBD0010

GUDID D745701164GBD00100

Glidewell™ 3DP Denture Teeth Resin Shade A4

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: D745701164GBD00100
• NIH Device Record Key: 631411da-a079-4ef5-9447-864ebdab045d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glidewell™ 3DP Denture Teeth Resin Shade A4
• Version Model Number: 70-1164-GBD0010
• Catalog Number: 70-1164-GBD0010
• 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	D745701164GBD00100 [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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• D745MAPCSDOP0 - Silent Nite 3D Sleep Appliance: 2024-04-23 Silent Nite 3D Sleep Appliance
• D745MAPCSDUA0 - Silent Nite 3D Sleep Appliance: 2024-04-23 Silent Nite 3D Sleep Appliance Upper Tray
• D745701184RAD0001 - BruxZir®: 2024-04-05 BruxZir® Radiant - Brite 14mm
• D745701184RAD0002 - BruxZir®: 2024-04-05 BruxZir® Radiant - Brite 16mm