Apex

GUDID D875S11684127104

Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.

MASTERLINK LLC

Dental digital imaging sensor, intraoral

• Primary Device ID: D875S11684127104
• NIH Device Record Key: 19a1104b-e91d-460e-9339-ae3214b05070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex
• Version Model Number: S11684-12-71
• Company DUNS: 017009932
• Company Name: MASTERLINK 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 869-0915
• Email: sean@dentalsensors.com
• Phone: (800) 869-0915
• Email: sean@dentalsensors.com

Device Dimensions

• Width: 25 Millimeter
• Width: 25 Millimeter
• Length: 39 Millimeter
• Width: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D875S11684127104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163282

FDA Product Code

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

Sterilization

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

[D875S11684127104]

Liquid Chemical

[D875S11684127104]

Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-18

On-Brand Devices [Apex]

• D875S11685127105: Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the
• D875S11684127104: Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the t