(83 days)
Not Found
Not Found
No
The device description and performance studies focus solely on the mechanical action of a manual toothbrush and do not mention any AI/ML components or functionalities.
'Yes'
The device is intended for treating and preventing gingivitis, which is a therapeutic claim.
No
A diagnostic device identifies a disease or condition. This device is a manual toothbrush, which is used for plaque removal and treating/preventing gingivitis, not for diagnosing these conditions.
No
The device description explicitly states it is a manual toothbrush comprised of a shaft with synthetic bristles, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Oral-B toothbrush described is a manual device used for mechanical cleaning of the teeth and gums. It physically removes plaque and helps prevent gingivitis.
- Lack of Biological Sample Testing: The device does not involve the collection or testing of any biological samples from the body. Its function is purely mechanical and external.
- Intended Use: The intended use is focused on oral hygiene and the physical removal of plaque, not on diagnosing or detecting any condition through the analysis of biological samples.
The information provided clearly indicates a mechanical device for oral hygiene, which falls outside the scope of in vitro diagnostics.
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)
EFW
Device Description
The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
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® manual toothbrushes have been tested in numerous controlled clinical studies. These trials evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health. In addition on:l soft and hard tissue safety was assessed. Collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque.
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.
Not Found
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
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end 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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
| 510(k) Summary | |
|---|---|
| Applicant: | Procter & Gamble |
| 8700 Mason-Montgomery Road | |
| Mason, OH 45202 | |
| Applicant Correspondent: | Michael A. Kaminski, Ph.D. |
| Senior Scientist, Regulatory Affairs Manager | |
| Procter & Gamble | |
| 8700 Mason-Montgomery Road | |
| Mason, OH 45202 |
FEB - 6 2008 |
| | Telephone: (513) 622-2879
Fax: (513) 622-1907
E-mail: kaminski.ma@pg.com |
| Date Summary Prepared: | October 12, 2007 |
| Proprietary Name of Device: | Oral-B® “sub-brand” manual toothbrush
(i.e. CrossAction, Advantage, Pulsar, Pro-Health) |
| Generic/Classification Name: | Toothbrush, Manual |
| Product Code (Classification): | EFW (Class I, 21CFR 872.6855) |
| Legally Marketed Predicate Devices: | Toothbrush, Manual EFW (21 CFR 872.6855)
Toothbrush, Power JEQ (21 CFR 872.6865) K061351 |
Device Description and Technical Characteristics: The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.
While manual toothbrushes are exempt devices, we believe the expansion of the indication to include for use of treating and preventing gingivitis may exceed the limitations of the 510(k) exemption. The expansion of the indication (treating and preventing gingivitis) is the only change from the currently marketed exempt device. There are no changes to the material, design or manufacturing process.
Indication for Use: To promote good oral hygier e including plaque removal and treating and preventing gingivitis.
Testing: Oral-B® manual toothbrushes have been tested in numerous controlled clinical studies. These trials evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health. In addition on:l soft and hard tissue safety was assessed. Collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque.
The information provided supports the safety and effectiveness of Oral-BBC Conclusions: manual toothbrushes and their substantial equivalence to the predicate devices without raising any new safety and effectiveness issues.
1
Bibliography
-
- M. J. Cronin, W. Dembling, N. Conforti, J. Liebman, M.A. Cugini, P. Warren: A single use and 3-month clinical inverstigation of the comparative efficacy of a battery-operated power toothbrush and a manual toothbrush. Special issue article Am J Dent 2001: 14:19B-24B
- N. Sharma, J. Qaqish, H. Galustians, D. King, M. Low, D. Jacobs, D. Weber: A 3-month r i comparative Investigation of the safety and c:Ticacy of a new toothbrush: Results from two independent clinical studies. Am J. Dent 2000, 13: Special Issue, 27A-32A
- A Six-Week clinical comparison of the Safety and Efficacy of Two manual Toothbrushes ﺘﻢ Hilltop Research. Inc. West palm Beach, Flerida, Final Report
- Nathoo S., Chaknis P., Petrone M., DeVizio W and Volpe AR: A Clinical Comparison of न the Gingivitis Reduction and Plaque-remov I Efficacy of a New Manual Toothbrush. Compendium 2004, 25(10) Suppl. 2:37-45
- Goyal C.R., Quaish J.G. and Galustians 1.: Efficacy and Safety of a New Power 5. Toothbrush in a population with Mild to Mederate Gingivitis. J Clin Dent 2007, 18:65-(59
- Yankell S.M., Emling R. and Percz B.: A Six-Month Clinical Evaluation of the Dentrust (). Toothbrush. J Clin Dent 1996, 7:106-109
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Michael A. Kaminski Senior Scientist, Regulatory Affairs Manager Procter & Gamble Company 8700 Mason-Montgomery Road Mason, Ohio 45040-9462
Re: K073224
Trade/Device Name: Oral-B® "sub-brand" manual toothbrush Regulation Number: 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: November 12, 2007 Received: November 15, 2007
Dear Dr. Kaminski:
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.
3
Page 2 – Dr. Kaminski
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin-Lin, Ph.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
4
Indication for Use
K673224 510(k) Number (if known):
Device Name: Oral-B® "sub-brand" manual toothbrush
Indication For Use:
To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Susan Dunne
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073224