Glidewell™ 3DP Denture Base Resin - Shade G1 70-1164-RSN0007

GUDID D745701164RSN00070

Glidewell TuffSplint™ Appliance Resin

James R. Glidewell, Dental Ceramics, Inc.

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• Primary Device ID: D745701164RSN00070
• NIH Device Record Key: 706dd78a-ab45-4d88-97ec-601d83716ab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glidewell™ 3DP Denture Base Resin - Shade G1
• Version Model Number: 70-1164-RSN0007
• Catalog Number: 70-1164-RSN0007
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• 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: 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

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701164RSN00070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223798

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2023-04-19
• Device Publish Date: 2023-04-11

On-Brand Devices [Glidewell™ 3DP Denture Base Resin - Shade G1]

• D745701164GBD00010: Glidewell™ 3DP Denture Base Resin - Shade G1
• D745701164RSN00070: Glidewell TuffSplint™ Appliance Resin