SIROSONIC

GUDID E27665628342

Set SIROSONIC L (2 pc.)

SIRONA Dental Systems GmbH

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: E27665628342
• NIH Device Record Key: 2fc7f18c-09c0-4786-ae87-5c194e6e16d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIROSONIC
• Version Model Number: 6562834
• Company DUNS: 340306351
• Company Name: SIRONA Dental Systems GmbH
• Device Count: 2
• 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	E27665628342 [Primary]
HIBCC	E27665638650 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033640

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

[E27665628342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [SIROSONIC]

• E27665628422: Set SIROSONIC TL (2 pc.)
• E27665628342: Set SIROSONIC L (2 pc.)
• E27662122160: SIROSONIC TL
• E27659135090: SIROSONIC L