MIXING TIP microSystem 60020183

GUDID J006600201830

Coltène/Whaledent AG

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: J006600201830
• NIH Device Record Key: 96d0da51-ce6a-495d-b9a0-9283f1a5666a
• Commercial Distribution Discontinuation: 2021-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MIXING TIP microSystem
• Version Model Number: 60020183
• Catalog Number: 60020183
• Company DUNS: 480017482
• Company Name: Coltène/Whaledent AG
• 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: true
• Lot Batch: false
• 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: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J006600201830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912485

FDA Product Code

• ELW: Material, Impression

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: 2021-11-22
• Device Publish Date: 2016-09-01

Devices Manufactured by Coltène/Whaledent AG

• J006600117570 - One Coat Bond: 2024-02-16
• J006600195380 - ONE COAT 7 UNIVERSAL: 2024-02-16
• J006600195390 - ONE COAT 7 UNIVERSAL: 2024-02-16
• J006600195400 - ONE COAT 7 UNIVERSAL: 2024-02-16
• J006600195410 - ONE COAT 7 UNIVERSAL: 2024-02-16
• J006600201000 - ONE COAT 7 UNIVERSAL: 2024-02-16
• J00670540 - ONE COAT 7.0: 2024-02-16
• J00673620 - A.R.T. BOND: 2024-02-16