KaVo GXS-700™ intraoral sensor

GUDID EKAV101291600

Size 2 Kit

GENDEX CORP.

Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101291600
• NIH Device Record Key: 0015b0ba-d919-4b0a-8be1-efaca4c05e7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo GXS-700™ intraoral sensor
• Version Model Number: 1.012.9160
• Company DUNS: 144575763
• Company Name: GENDEX CORP.
• 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	EKAV101291600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090458

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 GXS-700™ intraoral sensor]

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• EKAV101305120: Size 1 Kit
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• EKAV101291610: Size 1, Size 2 Kit
• EKAV101291600: Size 2 Kit
• EKAV101291590: Size 1 Kit
• EKAV101291580: Size 1, Size 2 Kit
• EKAV101291570: Size 2 Kit
• EKAV101291560: Size 1 Kit