Encore

GUDID 00817051020518

Encore Catalyst composite, 25g

CENTRIX, INC.

Dental composite resin

• Primary Device ID: 00817051020518
• NIH Device Record Key: 415ce516-282a-4ca9-878f-3c7e90bb3d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore
• Version Model Number: 310073
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051020518 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2018-03-29
• Device Publish Date: 2016-09-23

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• 00817051020556: Encore Natural without Fluoride composite kit
• 00817051020549: Encore Natural with Fluoride composite kit
• 00817051020532: Encore White without Fluoride composite kit
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• 00817051020518: Encore Catalyst composite, 25g
• 00817051020501: Encore White with Fluoride composite kit