(21 days)
Not Found
No
The device description focuses on mechanical features, timers, and pressure control, with no mention of AI or ML technologies.
Yes
The device is described as "effective at treating and preventing gingivitis," which aligns with the definition of a therapeutic effect.
No
Explanation: The device is described as an electric toothbrush intended for promoting oral hygiene, plaque removal, and treating/preventing gingivitis. Its description and intended use focus on mechanical cleaning and not on the diagnosis of medical conditions.
No
The device description clearly outlines a physical electric toothbrush with hardware components like a power handle, charging unit, brush head, bristles, and a pressure control mechanism. While it has features like a timer and different brushing modes, these are controlled by the hardware and not described as standalone software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To promote good oral hygiene including plaque removal and treating and preventing gingivitis." This is a direct therapeutic and preventative action on the human body (the mouth), not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device (electric toothbrush) designed for physical cleaning and stimulation of oral tissues. It does not describe any components or processes for analyzing biological samples (like blood, urine, saliva, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is clearly intended for direct use on the patient's mouth for hygiene and therapeutic purposes related to gingivitis, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.
Product codes (comma separated list FDA assigned to the subject device)
JEQ
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.
Oral-B® Sonic Complete™ product is a rechargeable battery operated toothbrush. The toothbrush handle is inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Oral-B® ® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis,
Quality assurance testing on the Oral-B® Sonic Complete™ electric toothbrush has been conducted to ensure the integrity of products.
Oral-B® Sonic Complete™ products are evaluated and comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K061351". The characters are written in a cursive style with a black pen on a white background. A horizontal line is drawn beneath the string.
510(k) SUMMARY
JUN - 5 2006
| Applicant: | Braun GmbH
Frankfurter Strasse 145
61476 Kronberg
Germany |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Amanda Heffernan
Manager, Regulatory Affairs
Clinical Research & Dental affairs
The Gillette Company
800 Boylston Street
Prudential Tower Building, Floor 46
Boston, MA 02199-8004 |
| | Telephone: 617.463.9532
Fax:
617.463.9578
Email: amanda_heffernan@gillette.com |
| Date summary prepared: | January 6, 2006 |
| Proprietary name of device: | Oral-B® Sonic Complete™ |
| Generic/classification name: | Toothbrush, Powered |
| Product code (classification): | JEQ (Class 1, 21 C.F.R. 872.6865) |
Legally Marketed Predicate Devices:
- Sonicare® Advance Toothbrush (K040416) . Philips Oral Healthcare, Inc.
- . Oral-B® Sonic Complete™ Braun GmbH
Device Description and Technological Characteristics:
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.
Page 1 of 3 in section 5.0
- 5.0
1
K06/351
510{k} SUMMARY Cont'd
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.
While power toothbrushes are 510(k) exempt device, we believe the expanded indication for use of treating and preventing gingivitis may exceed the limitation for 510(k) exemption. The expanded indications for use (i.e., treating and preventing gingivitis) are the only changes from the currently marketed device Oral-B® Sonic Complete™ . There are no changes to the design, materials or manufacturing process of this device.
Indications for Use:
To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.
Testing:
Oral-B® ® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis,
Quality assurance testing on the Oral-B® Sonic Complete™ electric toothbrush has been conducted to ensure the integrity of products.
Oral-B® Sonic Complete™ product is a rechargeable battery operated toothbrush. The toothbrush handle is inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the 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.
Oral-B® Sonic Complete™ products are evaluated and comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431).
Conclusions:
The results from these tests support the safety and effectiveness of Oral-B® Sonic Complete™ power toothbrush and its substantial equivalence to the predicate device without raising new safety or effectiveness issues.
Page 2 of 3 in section 5.0
2
510(k) SUMMARY Cont'd
Bibliography
-
- M.J. Cronin, W.Z. Dembling, M.A. Cugini, ; A 90 Day Clinical Comparison of the Safety and Efficacy of Two Toothbrushes, Final report: Study Number 01 16 04 03, Date of Report: April 5, 2004, New Institutional Service Co., Inc., Dental Research and Product Testing , Northfield, New Jersey
-
- N.A.M Rosema, M.F. Timmerman, M. Fiscaer, P.A. Versteeg, U. Van Der Velden, G.A. Van Der Weijden. ; Healing Effect of Experimental Gingivitis Using 2 Sonic Toothbrushes. Department of Periodontology, Academic Centre for Dentistry Amsterdam, 6 April 2004
Page 3 of 3 in section 5.0
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2006
Braun GmbH C/O Ms. Amanda Heffernan The Gillette Company 800 Boylston Street Prudential Tower Building, Floor 46 Boston, Massachusetts 02199-8004
Re: K061351
Trade/Device Name: Oral-B® Sonic Complete™ Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: I Product Code: JEQ Dated: May 11, 2006 Received: May 15, 2006
Dear Ms. Heffernan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Heffernan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sudie Y. Michael, M.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K06 1351
Indications for Use
510(k) Number (if known): _________________
Device Name: Oral-B® Sonic Complete™
Indications for Use: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
Anesthesiology, General Hospital, Son Control, Dental Dev
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Page 1 of 1 in section 4.0