Portrait® IPN® 20 Deg. Posteriors 16136

GUDID D00116136LP1333M0

Dentsply International 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 Resin artificial teeth

• Primary Device ID: D00116136LP1333M0
• NIH Device Record Key: 2b11782d-2f01-481b-9e48-32b56c890b1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portrait® IPN® 20 Deg. Posteriors
• Version Model Number: P13 L 33M
• Catalog Number: 16136
• Company DUNS: 606173334
• Company Name: Dentsply International 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: 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

Customer Support Contacts

• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D00116136LP1333M0 [Primary]

FDA Product Code

• ELM: Denture, plastic, teeth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-03-15
• Device Publish Date: 2016-09-21

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• D0026690011 - SmartCem®2 Self-Adhesive Cement: 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit
• D0026690031 - SmartCem®2 Self-Adhesive Cement: 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Evaluator Kit
• D0026070711 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Light, 2 (1.8g) syringe Refill Package
• D0026070721 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 2 (1.8g) syringe Refill Package
• D0026070731 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Dark, 2 (1.8g) syringe Refill Package
• D0026070741 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Translucent, 2 (1.8g) syringe Refill Package