ESSENTIALS

GUDID 07506338321631

ALGINATE ESSENTIALS ALL PURPOSE TYPE I 1LB

MDC DENTAL

Alginate dental impression material

• Primary Device ID: 07506338321631
• NIH Device Record Key: 9a57779c-044d-4999-a580-3f29bffedfa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENTIALS
• Version Model Number: ESSENTIALS
• Company DUNS: 811180298
• Company Name: MDC DENTAL
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx
• Phone: 3338330333
• Email: tecnovigilancia@dental.com.mx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506338321631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011785

FDA Product Code

• ELW: Material, Impression

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: 2023-06-13
• Device Publish Date: 2023-06-05

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• 07506338321938 - ROGSON WAX, MDC Dental: 2024-04-19 Green Color Adhesive Prefabricated Plastic Shape Corrugated Short Curved Retainer CR-1
• 07506338321945 - ROGSON WAX, MDC Dental: 2024-04-19 Green Adhesive Prefabricated Plastic Shape Corrugated Long Curved Retainer Gauge CF2 111t
• 07506338321952 - ROGSON WAX, MDC Dental: 2024-04-19 Green Color Adhesive Prefabricated Plastic Shape Long Straight Retainer SC2
• 07506338321969 - ROGSON WAX, MDC Dental: 2024-04-19 " Green adhesive prefabricated plastic form simple racket No. 6 LR6"
• 07506338321976 - ROGSON WAX, MDC Dental: 2024-04-19 Green adhesive prefabricated plastic form lingual bar LB1"
• 07506338321778 - ROGSON WAX, MDC Dental: 2024-02-29 Rogson Wax, Adhesive Prefabricated Plastic Form, green, corrugated, 22/22 gauge (GA), medium, 8 pieces.