Nic Tone Softy, MDC Dental

GUDID 07506338320139

NIC TONE SOFTY Normal Acrylic, complete Kit 5 pcs

MDC DENTAL

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• Primary Device ID: 07506338320139
• NIH Device Record Key: a2f51a01-1c56-4c85-b412-cc99b4d4eb9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nic Tone Softy, MDC Dental
• Version Model Number: Complete Normal Kit
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07506338320139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991577

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [ Nic Tone Softy, MDC Dental]

• 07506338320139: NIC TONE SOFTY Normal Acrylic, complete Kit 5 pcs
• 07506338320160: NIC TONE SOFTY Rapid Acrylic, Soft Acrylic Base, 40 ml
• 07506338320153: NIC TONE SOFTY Rapid Acrylic, Soft Acrylic Base, 80 g
• 07506338320146: NIC TONE SOFTY Normal Acrylic, Replacement Kit, 2 pcs
• 07506338320122: NIC TONE SOFTY Normal Acrylic, Soft Acrylic Base, 40 ml
• 07506338320115: NIC TONE SOFTY Rapid Acrylic, Soft Acrylic Base, 80 g
• 07506338320108: NIC TONE SOFTY Rapid Acrylic, Replacement Kit, 3 pcs