KaVo IXS Size 1 Sensor Kit

GUDID EKAV101397160

Imaging Sciences International

Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101397160
• NIH Device Record Key: 5ab0a424-9fce-47ad-8ec4-86fc34a19787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo IXS Size 1 Sensor Kit
• Version Model Number: 1.013.9716
• Company DUNS: 800111106
• Company Name: Imaging Sciences International
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101397160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172918

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [KaVo IXS Size 1 Sensor Kit]

• EKAV101461040: 1.014.6104
• EKAV101397180: 1.013.9718
• EKAV101397170: 1.013.9717
• EKAV101397160: 1.013.9716