MIXING TIP microSystem 60020183

GUDID J006600201830

Coltène/Whaledent AG

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

• J0006600332800 - BRILLIANT Bulk Fill Flow: 2024-09-30
• J0006600368240 - BRILLIANT Bulk Fill Flow: 2024-09-30
• 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