Basic 6, D2 / L02, CE 56739094

GUDID J014567390940

Preformed plastic denture tooth

Heraeus Kulzer GmbH

Resin artificial teeth

• Primary Device ID: J014567390940
• NIH Device Record Key: f9fc48b7-083e-4de3-bafa-ce6b6ddc405e
• Commercial Distribution Discontinuation: 2022-06-10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Basic 6, D2 / L02, CE
• Version Model Number: 56739094
• Catalog Number: 56739094
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014567390940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000213

FDA Product Code

• ELM: Denture, plastic, teeth

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: 2022-06-09
• Device Publish Date: 2016-09-15

Devices Manufactured by Heraeus Kulzer GmbH

• J014500354060 - PROVIL NOVO L. 1X280 ML: 2024-09-17 Material, Impression
• J014500354120 - PROVIL NOVO P SOFT FAST 1X500: 2024-09-17 Material, Impression
• J014656875141 - IOT white 96: 2024-09-17 Syringe, Restorative and Impression Material
• J014657670380 - CUTTERSIL P PLUS 1X900 ML: 2024-09-17 Material, Impression
• J014658179300 - CUTTERSIL LIGHT GREEN 1X140 ML: 2024-09-17 Material, Impression
• J014660007810 - Dispensing Gun 4:1: 2024-09-17 Instruments, Dental Hand
• J014660007821 - IOT yellow 96: 2024-09-17 Syringe, Restorative and Impression Material
• J014660009051 - BITE REG INTRAORAL TIP CD 96: 2024-09-17 Syringe, Restorative and Impression Material