ACRY SMART DIGITAL 0120110

GUDID 28056865152428

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 28056865152428
• NIH Device Record Key: b18372cc-8b3e-4750-96e1-d0e83781ff40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY SMART DIGITAL
• Version Model Number: ACRY SMART DIGITAL 8 LOWER
• Catalog Number: 0120110
• Company DUNS: 435782248
• Company Name: DENTAL MANUFACTURING SPA
• Device Count: 12
• 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	08056865152424 [Primary]
GS1	18056865152421 [Unit of Use]
GS1	28056865152428 [Package]; Contains: 08056865152424; Package: [12 Units]; In Commercial Distribution

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