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510(k) Data Aggregation
K Number
K200881Device Name
Oral-B iO Test Drive Power Brush Trial Program Kit
Manufacturer
The Procter & Gamble Company
Date Cleared
2020-08-27
(147 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
Device Description
The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
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K Number
K141018Device Name
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
Manufacturer
PROCTER & GAMBLE CO.
Date Cleared
2014-09-15
(147 days)
Product Code
JEQ, JEO
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.
The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.
Device Description
The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.
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K Number
K061351Device Name
ORAL-B SONIC COMPLETE
Manufacturer
BRAUN GMBH
Date Cleared
2006-06-05
(21 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
Device Description
Oral-B® Sonic Complete™ is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power handle. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® Sonic Complete™ electric toothbrush has a vibrating brush head that moves with a side-to-side movement. The brush head is designed to facilitate deeper penetration of interdental areas. The brush head moves side along the axis of the brush head at 260 Hz at an unloaded angle of ± 5 degrees. The brush head has no moving parts and is similar to a manual brush. The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12. The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.
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K Number
K061199Device Name
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
Manufacturer
BRAUN GMBH
Date Cleared
2006-05-31
(33 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
Device Description
Oral-B® ProfessionalCare/Oral-B® AdvancePower is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power unit. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® ProfessionalCare/Oral-B® AdvancePower electric toothbrush has an oscillating/rotating technology, a small round brush head that aids tooth-to-tooth cleaning. The brush head is designed to facilitate deeper penetration of interdental areas. The action of the brush head has an oscillation range frequency between 63 to 73 Hz with a vibration frequency of 340 Hz (3800 strokes per minute) and an oscillating range angle of 42° to 60° depending on the toothbrush model.
The brush head design is a small circular brush head and features an arrangement of flagged bristles and power tips. The power tips have tufts of longer bristles on either side of the brush head in the outer ring. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2.
The flagged bristle tufts have tetralocular filaments and are designed to increase the brushing action on tooth surfaces. The bristle material is Polyamid or PA6.12. The toothbrush features a round handle with anti-slip characteristics for better control in wet conditions and offers a variable range of speeds to best meet individual needs.
Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are rechargeable battery operated toothbrushes. The toothbrush handles are inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the product is provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.
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K Number
K040416Device Name
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
Manufacturer
PHILIPS ORAL HEALTHCARE, INC.
Date Cleared
2004-07-02
(135 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.
Device Description
Sonicare® Advance Model 4900 consists of three primary parts: brush head, power handle, and charger base. Central to the brush head are the resonator arm and the torsion bar. The brush head's bristles are mounted in a bristle plate on one end of the arm, two magnets are mounted on the other, and the torsion bar is perpendicular in the middle. A 261-Hz oscillating magnetic flux generated inside the power handle forces the magnets into motion, which then causes the resonator arm to oscillate about the torsion bar. The torsion bar, magnets and bristle plate have a resonant frequency close to the 261-Hz driving frequency, and this enables the system to produce a desired amplitude effect. The bristles vibrate in the direction perpendicular to the bristles' length and nominally perpendicular to the brush's axis.
The oscillating magnetic flux is generated by a stator coil in the power handle, in close proximity to the attachment of the brush head. The flux is controlled by solid-state electronics and powered from two nickel-cadmium rechargeable batteries elsewhere within the handle. Energy for recharging the batteries is transferred from the charger base through a system of induction coils within the power handle and the charger base. Maximum power dissipation by the handle is 3 W.
The charger base runs on standard North American 120 V, 60 Hz power. Internal electronics convert the input power to a 65 kHz output signal for more efficient transfer of power to the handle.
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K Number
K022900Device Name
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
Manufacturer
JOHN O. BUTLER CO.
Date Cleared
2002-11-14
(72 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.
Device Description
The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.
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K Number
K012914Device Name
SONICWAVE SONIC PLAQUE REMOVER
Manufacturer
HOMEDICS, INC.
Date Cleared
2001-10-01
(32 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
Device Description
This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.
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K Number
K970381Device Name
POWERED TOOTHBRUSH
Manufacturer
EMJOI ACTION USA, LTD.
Date Cleared
1997-04-18
(74 days)
Product Code
JEQ
Regulation Number
872.6865Why did this record match?
Product Code :
JEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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