ISOTEK, MDC Dental

GUDID 17506338322413

Box with 30 tablets of acrylic resin tooth Anterior

MDC DENTAL

Resin artificial teeth

• Primary Device ID: 17506338322413
• NIH Device Record Key: d32ea52d-66f5-4907-a136-e5935e6a026c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOTEK, MDC Dental
• Version Model Number: Anterior
• Company DUNS: 811180298
• Company Name: MDC DENTAL
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• 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	07506338322416 [Primary]
GS1	17506338322413 [Unit of Use]

FDA Product Code

• ELK: Teeth, Artificial, Backing And Facing

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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [ISOTEK, MDC Dental]

• 17506338322420: Box with 20 acrylic resin tooth tablets Posterior
• 17506338322413: Box with 30 tablets of acrylic resin tooth Anterior