DEXIS Platinum™ intraoral sensor PLU5109I

GUDID EKAV101184190

Digital intraoral sensor

DEXIS LLC

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101184190
• NIH Device Record Key: 003602c7-7c51-4808-aec6-f84491f35963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Platinum™ intraoral sensor
• Version Model Number: 1.011.8419
• Catalog Number: PLU5109I
• Company DUNS: 019717844
• Company Name: DEXIS LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101184190 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [DEXIS Platinum™ intraoral sensor]

• EKAV101184190: Digital intraoral sensor
• EKAV101184180: Digital intraoral sensor
• EKAV101184170: Digital intraoral sensor
• EKAV100898770: Digital intraoral sensor
• EKAV100898740: Digital intraoral sensor
• EKAV100730420: Digital intraoral sensor
• EKAV082251940: Digital intraoral sensor
• EKAV082250740: Digital intraoral sensor
• EKAV082250730: Digital intraoral sensor
• EKAV082250710: Digital intraoral sensor