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510(k) Data Aggregation
K Number
K121165Device Name
BEAM BRUSH/BEAM APP
Manufacturer
BEAM TECHNOLOGIES, LLC
Date Cleared
2012-06-21
(65 days)
Product Code
EFW
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
BEAM TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
Device Description
The Beam Brush is a manual toothbrush comprised essentially of a shaft with synthetic bristles on one end that are used to remove plaque and food debris from its user's teeth. The bristle material is Nylon 612 or Polyamide 612. The Beam Brush collects brushing usage data based on the principle that the human body possesses the property of being a good capacitor, such that the human body has a detectable capacitance. This capacitance is transferrable through a thermoplastic material. The Beam Brush comprises a capacitive sensor, which is completely enclosed in the toothbrush body. The capacitive sensor detects that the Beam Brush is in use based on the capacitance introduced by the human body when the Beam Brush is utilized for its intended purpose. The Beam Brush wirelessly transmits the collected data using radio frequency transmission, more specifically Bluetooth® radio. The Bluetooth® standard defines the parameters for transmission of data via radio frequency including a transmitting frequency of 2.4 GHz. The Beam Brush is a Class 2 Bluetooth® device, which has a transmission range of about 30 feet and a maximum power of 2.5 mW. The data is received by a user's own mobile device that runs a software application (Beam App), which is of a minor level of concern. The Beam App is an accessory to the Beam Brush and allows the user to view his/her brushing usage data for the user's convenience and education. The Beam App, collection of data, and transmission of data are not intended for the diagnosis and treatment of disease or to affect the structure or function of the body. The Beam Brush's capacitive sensor and Bluetooth® radio are powered by a single AA alkaline battery that is replaceable. The Beam Brush also comprises a replaceable brush head that connects to the handle at the base of the neck.
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