ACRY FORM 0031003

GUDID 18056865003136

DENTAL MANUFACTURING SPA

Resin artificial teeth

• Primary Device ID: 18056865003136
• NIH Device Record Key: 9119e9be-89e5-4803-ba13-ec51af915f3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY FORM
• Version Model Number: ACRY FORM 8 UPPER
• Catalog Number: 0031003
• 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	08056865003139 [Primary]
GS1	18056865003136 [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: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [ACRY FORM ]

• 18056865003143: ACRY FORM 8 LOWER
• 18056865003136: ACRY FORM 8 UPPER
• 18056865003129: ACRY FORM 6 LOWER
• 18056865003112: ACRY FORM 6 UPPER