SPRAYVIT

GUDID E27641760170

SPRAYVIT 6-way syringe w light,left

SIRONA Dental Systems GmbH

Dental delivery system irrigation handpiece

• Primary Device ID: E27641760170
• NIH Device Record Key: 9c0fa7c5-864c-4cd3-939a-2b89ec4af856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRAYVIT
• Version Model Number: 4176017
• 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	E27641760170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151045

FDA Product Code

• EBW: Controller, Foot, Handpiece And Cord

Sterilization

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

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

Moist Heat or Steam Sterilization

[E27641760170]

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: 2016-09-23

On-Brand Devices [SPRAYVIT]

• E27664362030: Sprayvit E (L)
• E27664361950: Sprayvit E (R)
• E27641760170: SPRAYVIT 6-way syringe w light,left
• E27633270090: SPRAYVIT handp.light,heating,right