ACRY LUX V. 0090010

GUDID 18056865009107

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 18056865009107
• NIH Device Record Key: f97b4188-6243-456a-b880-04987e115a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY LUX V.
• Version Model Number: ACRY LUX V. 6 LOWER
• Catalog Number: 0090010
• 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	08056865009100 [Primary]
GS1	18056865009107 [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: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [ACRY LUX V. ]

• 18056865009121: ACRY LUX V. 8 LOWER
• 18056865009114: ACRY LUX V. 8 UPPER
• 18056865009107: ACRY LUX V. 6 LOWER
• 18056865009091: ACRY LUX V. 6 UPPER