ACRY LUX 0090001

GUDID 08056865009018

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 08056865009018
• NIH Device Record Key: 791b2794-c7fe-42e2-8cb5-176283f7f6c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY LUX
• Version Model Number: ACRY LUX 6 UPPER
• Catalog Number: 0090001
• Company DUNS: 435782248
• Company Name: DENTAL MANUFACTURING SPA
• Device Count: 6
• 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	08056865009018 [Primary]
GS1	18056865009015 [Package]; Package: [18 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-08
• Device Publish Date: 2020-02-21

On-Brand Devices [ACRY LUX ]

• 08056865009025: ACRY LUX 6 LOWER
• 08056865009018: ACRY LUX 6 UPPER