Perfectim Final Wash

GUDID 10852253006080

PVS Dental Impression Material

J. MORITA U.S.A., INC

Silicone dental impression material

• Primary Device ID: 10852253006080
• NIH Device Record Key: 5917c7aa-3d72-44d0-a4ca-15b745a1c421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfectim Final Wash
• Version Model Number: 21300800
• Company DUNS: 021866033
• Company Name: J. MORITA U.S.A., INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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	10852253006080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964692

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-28
• Device Publish Date: 2016-09-22

On-Brand Devices [Perfectim Final Wash]

• 18522530060082: PVS Dental Impression Material
• 10852253006080: PVS Dental Impression Material