ACRY SMART 0120092

GUDID 08056865012926

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 08056865012926
• NIH Device Record Key: 3a41ecca-8545-4112-85c3-7335b47c199e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY SMART
• Version Model Number: ACRY SMART 8 UPPER
• Catalog Number: 0120092
• 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	08056865012926 [Primary]
GS1	18056865012923 [Unit of Use]
GS1	28056865012906 [Unit of Use]
GS1	28056865012920 [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