ACRY PLUS EVO RX 0120050

GUDID 08056865012506

ACRY PLUS EVO RX 8 LOWER

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 08056865012506
• NIH Device Record Key: ff267105-2b1d-47b5-8be2-e92fd738251a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY PLUS EVO RX
• Version Model Number: ACRY PLUS EVO RX 8 LOWER
• Catalog Number: 0120050
• 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	08056865012506 [Primary]
GS1	18056865012503 [Unit of Use]
GS1	28056865012500 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	28056865012906 [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: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [ACRY PLUS EVO RX ]

• 08056865012506: ACRY PLUS EVO RX 8 LOWER
• 08056865012490: ACRY PLUS EVO RX 8 UPPER
• 08056865012483: ACRY PLUS EVO RX 6 LOWER
• 08056865012476: ACRY PLUS EVO RX 6 UPPER