ACRY SMART DIGITAL 0120107

GUDID 18056865152391

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 18056865152391
• NIH Device Record Key: 28fc1f0c-c651-49a0-b466-215335f88c4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY SMART DIGITAL
• Version Model Number: ACRY SMART DIGITAL 6 UPPER
• Catalog Number: 0120107
• Company DUNS: 435782248
• Company Name: DENTAL MANUFACTURING SPA
• Device Count: 18
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056865152394 [Primary]
GS1	18056865152391 [Package]; Contains: 08056865152394; Package: [18 Units]; In Commercial Distribution
GS1	28056865152398 [Unit of Use]

FDA Product Code

• PZY: Additively Manufactured, Preformed, Resin Denture Tooth

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: 2024-02-05
• Device Publish Date: 2024-01-26

On-Brand Devices [ACRY SMART DIGITAL]

• 28056865152428: ACRY SMART DIGITAL 8 LOWER
• 28056865152411: ACRY SMART DIGITAL 8 UPPER
• 18056865152407: ACRY SMART DIGITAL 6 LOWER
• 18056865152391: ACRY SMART DIGITAL 6 UPPER