DEXIS Platinum™ intraoral sensor PLU5102C

GUDID EKAV082250730

Digital intraoral sensor

DEXIS LLC

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• Primary Device ID: EKAV082250730
• NIH Device Record Key: a331dd8d-c6e7-4474-ad47-a0499fe8698e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Platinum™ intraoral sensor
• Version Model Number: 0.822.5073
• Catalog Number: PLU5102C
• 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	EKAV082250730 [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