INTEGO pro TS ambidextrous with disinfection

GUDID E27665918580

Treatment Center INTEGO pro TS ambidextrous with disinfection

SIRONA Dental Systems GmbH

Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system

• Primary Device ID: E27665918580
• NIH Device Record Key: 5b7f14f1-d8cd-48d5-be13-9d6d9bf98c7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGO pro TS ambidextrous with disinfection
• Version Model Number: 6591858
• Company DUNS: 340306351
• Company Name: SIRONA Dental Systems GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E27665918580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150909

FDA Product Code

• EIA: Unit, Operative Dental

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: 2016-09-10

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