Encore

GUDID 00817051020556

Encore Natural without Fluoride composite kit

CENTRIX, INC.

Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 00817051020556
• NIH Device Record Key: 2548e601-b2ff-4e01-bf89-18db2a521dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore
• Version Model Number: 310077
• 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: true
• 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	00817051020556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921174

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Encore]

• 00817051021362: Encore DC Contrast Blue with Fluoride 25ml cartridge
• 00817051021355: Encore DC Natural with Fluoride 25ml cartridge
• 00817051021348: Encore DC Natural Minimix composite, 12 pk
• 00817051020624: Encore DC Contrast Minimix composite, 36 pk
• 00817051020617: Encore DC Natural Minimix composite, 36 pk
• 00817051020600: Encore DC Contrast Minimix composite, 12 pk
• 00817051020594: Encore DC Natural Minimix composite, 12 pk
• 00817051020570: Encore AF Natural with Fluoride composite, 25g base & 25g catalyst
• 00817051020563: Encore AF White with Fluoride composite, 25g base & 25g catalyst
• 00817051020556: Encore Natural without Fluoride composite kit
• 00817051020549: Encore Natural with Fluoride composite kit
• 00817051020532: Encore White without Fluoride composite kit
• 00817051020525: Encore Base composite, 25g
• 00817051020518: Encore Catalyst composite, 25g
• 00817051020501: Encore White with Fluoride composite kit