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

• 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

Devices Manufactured by Prismatik Dentalcraft, Inc

• D745701075ZST00760 - Inclusive®: 2026-03-02 Inclusive® Abutment Analog compatible with: LOCATOR® Abutment
• D745701161COM00010 - Inclusive®: 2025-12-09 Inclusive® Titanium Abutment Blank compatible with: CONELOG® Ø3.3 mm
• D745701161COM00020 - Inclusive®: 2025-12-09 Inclusive® Titanium Abutment Blank compatible with: CONELOG® Ø3.8/4.3 mm
• D745701161COM00040 - Inclusive®: 2025-12-09 Inclusive® Titanium Abutment Blank compatible with: CONELOG® Ø5.0 mm
• D745701161COM00050 - Inclusive®: 2025-12-09 Inclusive® GL Titanium Abutment 4.5 mmH compatible with: CONELOG® Ø3.3 mm
• D745701161COM00060 - Inclusive®: 2025-12-09 Inclusive® GL Titanium Abutment 4.5 mmH compatible with: CONELOG® Ø3.8/4.3 mm
• D745701161COM00080 - Inclusive®: 2025-12-09 Inclusive® GL Titanium Abutment 4.5 mmH compatible with: CONELOG® Ø5.0 mm
• D745701161COM00090 - Inclusive®: 2025-12-09 Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: CONELOG® Ø3.3 mm