SmartCem®2 Self-Adhesive Cement 669001

GUDID D0026690011

SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit

DENTSPLY INTERNATIONAL INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: D0026690011
• NIH Device Record Key: 1467d054-a363-4fa1-ada4-947a4d13455f
• Commercial Distribution Discontinuation: 2024-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SmartCem®2 Self-Adhesive Cement
• Version Model Number: 669001
• Catalog Number: 669001
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0
• Weight: 5 Gram
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026690011 [Primary]

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2024-05-03
• Device Publish Date: 2016-09-21

On-Brand Devices [SmartCem®2 Self-Adhesive Cement]

• D0026690041: SmartCem®2 Self-Adhesive Cement Syringe Sampler
• D0026690031: SmartCem®2 Self-Adhesive Cement Syringe Evaluator Kit
• D0026690011: SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit