ACRY PLUS EVO 0120038

GUDID 18056865012381

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 18056865012381
• NIH Device Record Key: c7b57925-ed7f-4fb3-9e21-0073410fb875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY PLUS EVO
• Version Model Number: ACRY PLUS EVO 8 UPPER
• Catalog Number: 0120038
• 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	08056865012384 [Primary]
GS1	18056865012381 [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: 2020-03-05
• Device Publish Date: 2020-02-26

On-Brand Devices [ACRY PLUS EVO ]

• 18056865012398: ACRY PLUS EVO 8 LOWER
• 18056865012381: ACRY PLUS EVO 8 UPPER
• 18056865012374: ACRY PLUS EVO 6 LOWER
• 18056865012367: ACRY PLUS EVO 6 UPPER