Durafill VS 66000022

GUDID J014660000220

Durafill VS Syr 1 x 4 G-OA3

Heraeus Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660000220
• NIH Device Record Key: 11ce217a-74b9-4b7f-b317-dbc38dc56754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durafill VS
• Version Model Number: 66000022
• Catalog Number: 66000022
• Company DUNS: 315666321
• Company Name: Heraeus Kulzer GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX
• Phone: +1(800)431-1785
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660000220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811669

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: 4
• Public Version Date: 2023-07-18
• Device Publish Date: 2016-09-23

On-Brand Devices [Durafill VS]

• J014660024990: Durafill VS Syr 1 x 4 G-SSL
• J014660000300: Durafill VS PLT 2 x 10 x 0,25G-A3,5
• J014660000290: Durafill VS PLT 2 x 10 x 0,25G-A3
• J014660000280: Durafill VS PLT 2 x 10 x 0,25G-A2
• J014660000270: Durafill VS PLT 2 x 10 x 0,25G-A1
• J014660000260: Durafill VS Syr 1 x 4 G-I
• J014660000250: Durafill VS Syr 1 x 4 G-SL
• J014660000230: Durafill VS Syr 1 x 4 G-OA3,5
• J014660000220: Durafill VS Syr 1 x 4 G-OA3
• J014660000210: Durafill VS Syr 1 x 4 G-OA2
• J014660000200: Durafill VS Syr 1 x 4 G-D3
• J014660000190: Durafill VS Syr 1 x 4 G-C4
• J014660000180: Durafill VS Syr 1 x 4 G-C3
• J014660000170: Durafill VS Syr 1 x 4 G-C2
• J014660000160: Durafill VS Syr 1 x 4 G-C1
• J014660000150: Durafill VS Syr 1 x 4 G-B3
• J014660000140: Durafill VS Syr 1 x 4 G-B2
• J014660000130: Durafill VS Syr 1 x 4 G-B1
• J014660000120: Durafill VS Syr 1 x 4 G-A4
• J014660000110: Durafill VS Syr 1 x 4 G-A3,5
• J014660000100: Durafill VS Syr 1 x 4 G-A3
• J014660000090: Durafill VS Syr 1 x 4 G-A2
• J014660000080: Durafill VS Syr 1 x 4 G-A1