DEXIS Titanium Warranty Replacement

GUDID EKAV101329490

Imaging Sciences International

Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101329490
• NIH Device Record Key: dcb10bb2-f07b-4fc2-9385-5e77e54a3d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Titanium Warranty Replacement
• Version Model Number: 1.013.2949
• 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	EKAV101329490 [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

Devices Manufactured by Imaging Sciences International

• EKAV083081000 - KaVo OP 3D Vision: 2022-01-31 V8
• EKAV083082000 - KaVo OP 3D Vision: 2022-01-31 V10
• EKAV083083000 - KaVo OP 3D Vision: 2022-01-31 V17
• EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R: 2022-01-31
• EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R: 2022-01-31
• EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor: 2022-01-31
• EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor: 2022-01-31
• EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor: 2022-01-31