(84 days)
Not Found
No
The summary describes a manual toothbrush with antibacterial filaments. There is no mention of any computational or algorithmic components, let alone AI or ML.
No
The device is a toothbrush intended for removing plaque and debris and preventing tooth decay, which are general hygiene and preventative measures, not therapeutic treatments for a specific disease or condition.
No
The Medoral Hygienic Toothbrush is described as a device for removing plaque and debris and preventing tooth decay, and its function involves an antibacterial agent. There is no mention of it being used to diagnose a condition or disease.
No
The device description clearly indicates it is a physical toothbrush with antibacterial filaments, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove plaque and debris from teeth and prevent tooth decay. This is a physical action on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a toothbrush with antibacterial filaments. This is a physical tool for oral hygiene.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition. The antibacterial agent's purpose is to keep the toothbrush clean, not to diagnose anything.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This toothbrush does not fit that description.
N/A
Intended Use / Indications for Use
The Medoral Hygienic Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use.
The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
Product codes (comma separated list FDA assigned to the subject device)
EFW
Device Description
The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use
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)
The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices.
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.
Reach Antibacterial Toothbrush K971589, Crest Toothbrush with Microshield K973236, Butler Antibacterial Interdental Toothbrush K974761
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
Section E - 510(k) Summary
1020776
March 5, 2000
| Applicant: | CORONET GROUP North America, LLC
175 Dwight Road, Suite 200
Longmeadow, MA 01106
Phone: 413-565-4602 Fax: 413-565-4603 |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Preparer &
Correspondent | Thomas E. Ferari
Medical Device Consultant
181 Dixon Road
Queensbury, NY 12804
Phone - 518-792-2258 Fax: 518-792-2274
email - tferari@aol.com |
| Proprietary Device Name:
Common Device Name:
Classification Name: | Medoral Hygienic Toothbrush with DENTOSAN® Filaments
Antibacterial Toothbrush Filament
Manual Toothbrush (Class I Device Ref 21CFR 872.6855) |
| Predicate Devices: | Reach Antibacterial Toothbrush K971589
Crest Toothbrush with Microshield K973236
Butler Antibacterial Interdental Toothbrush K974761 |
Device Description: The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
Intended Use: The Medoral Hygienic Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use.
Technological Characteristics: The DENTOSAN® filament is impregnated with a high level of silver to prevent the growth of bacteria on or between the toothbrush bristles. The active ingredient is distributed throughout the nylon filament and provides long lasting antimicrobial action.
1
Substantial Equivalence Assessment: All of the predicate devices are toothbrushes with antibacterial ingredients incorporated into them. Although the antibacterial agents (triclosan and chlorhexidine/zinc oxide) are different, in the predicate devices, their effect is comparable to the silver used in the DENTOSAN® filament. The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices.
Summary:
The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns. The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols. Therefore, the Medoral Hygienic Toothbrush with DENTOSAN® filaments is believed to be substantially equivalent to the predicate devices.
Image /page/1/Picture/3 description: The image shows the date 3/5/02. The date is written in a simple, sans-serif font. The numbers are clearly legible.
5
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
C/O Mr. Thomas E. Ferari Medical Device Consultant Coronet Group North America, LLC 181 Dixion Road Queensbury, New York 12804
Re: K020776
Trade/Device Name: Medoral Hygienic Toothbrush with DENTOSAN® Filaments Regulation Number: 872.6855 Regulation Name: Toothbrush with Antibacterial Filament Regulatory Class: I Product Code: EFW Dated: March 5, 2002 Received: March 11, 2002
Dear Mr. Ferari
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.
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
3
Page 2 - Mr. Ferari
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 (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613dditionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Patricio Cusenite ffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K02076
Section D - Statement of Indications for Use
| 510(k) Number: | TBD |
|---|---|
| Applicant: | CORONET GROUP North America, LLC |
| 175 Dwight Road, Suite 200 | |
| Longmeadow, MA 01106 | |
| Phone: 413-565-4602 Fax: 413-565-4603 | |
| Proprietary Device Name: | Medoral Hygienic Toothbrush with DENTOSAN® Filament |
Intended Use: The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
ABgotz for Dr Ruener
(Division Sign Division of Dental, Infection Control, and General Hospital 5 10(k) Number _