ACRY SMART 0120093

GUDID 08056865012933

DENTAL MANUFACTURING SPA

Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth

• Primary Device ID: 08056865012933
• NIH Device Record Key: 49810699-2a04-444c-b37c-c787501114ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY SMART
• Version Model Number: ACRY SMART 8 LOWER
• Catalog Number: 0120093
• Company DUNS: 435782248
• Company Name: DENTAL MANUFACTURING SPA
• Device Count: 8
• 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	08056865012933 [Primary]
GS1	18056865012930 [Unit of Use]
GS1	28056865012906 [Unit of Use]
GS1	28056865012937 [Package]; 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: 2020-02-19
• Device Publish Date: 2020-02-11

On-Brand Devices [ACRY SMART ]

• 08056865012933: ACRY SMART 8 LOWER
• 08056865012926: ACRY SMART 8 UPPER
• 08056865012919: ACRY SMART 6 LOWER
• 08056865012902: ACRY SMART 6 UPPER