Perflex AcryFree Easyclasp 333005

GUDID 07290110501297

AcryFree Thermoplastic Easyclasp Shade Clear/Transparent 10 units jar

PERFLEX LTD

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 07290110501297
• NIH Device Record Key: a410850a-9b02-4e39-8c5a-c13898b0ea50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perflex AcryFree Easyclasp
• Version Model Number: EC-Clear 10 units jar
• Catalog Number: 333005
• Company DUNS: 532176000
• Company Name: PERFLEX LTD
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97298825473
• Email: vidal@perflexltd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110501297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150454

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [Perflex AcryFree Easyclasp]

• 07290110501303: AcryFree Thermoplastic Easyclasp Shade Opaque Pink "N5" 10 units jar
• 07290110501297: AcryFree Thermoplastic Easyclasp Shade Clear/Transparent 10 units jar