SIROSONIC

GUDID E27659135090

SIROSONIC L

SIRONA Dental Systems GmbH

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: E27659135090
• NIH Device Record Key: 0d253506-6c56-47b5-9195-43469393c22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIROSONIC
• Version Model Number: 5913509
• 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	E27659135090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033640

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

Moist Heat or Steam Sterilization

[E27659135090]

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