ACRY PLUS 0120013

GUDID 18056865012138

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 18056865012138
• NIH Device Record Key: ceecb60b-f624-4252-b004-4c6ed4d07cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY PLUS
• Version Model Number: ACRY PLUS 8 LOWER
• Catalog Number: 0120013
• 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	08056865012131 [Primary]
GS1	18056865012138 [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: 2020-02-27
• Device Publish Date: 2020-02-19

On-Brand Devices [ACRY PLUS ]

• 18056865012138: ACRY PLUS 8 LOWER
• 18056865012121: ACRY PLUS 8 UPPER
• 18056865012114: ACRY PLUS 6 LOWER
• 18056865012107: ACRY PLUS 6 UPPER