(195 days)
Not Found
No
The device description and other sections do not mention any AI or ML capabilities. The device is described as a manual toothbrush with an antimicrobial agent.
No.
The primary purpose of the device is for cleaning teeth, and while it mentions preventing tooth decay and bacterial growth on the brush, these are hygiene and maintenance functions rather than directly treating a medical condition or restoring a bodily function. Its classification as a manual toothbrush and predicate devices further support it not being a therapeutic device.
No
The device is a manual toothbrush intended for mechanical removal of plaque and food debris and to prevent bacterial growth on the brush itself. It does not identify or analyze any medical condition or disease.
No
The device description clearly states it is a "manual toothbrush consisting of a shaft with synthetic bristles," which are physical hardware components.
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 food debris from teeth and prevent bacterial growth on the toothbrush itself. This is a mechanical action and a surface treatment, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description confirms it's a manual toothbrush with bristles and an antimicrobial agent for the brush. It doesn't involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or determine compatibility.
The device is clearly intended for oral hygiene and preventing bacterial growth on the toothbrush, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To remove adherent plaque and food debris from the teeth to prevent tooth decay.
To prevent the growth of bacterial between brushings to maintain the cleanliness of the toothbrush.
Product codes
EFW
Device Description
The Crest Toothbrush with MicroShield is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Procter&Gamble
The Procter & Gamble Company Health Care Research Center 8700 Mason-Montgomery Road, Mason, Ohio 45040-9462
MAR 11 1998
Premarket Notification [510(k)] Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR §807.92(c).
Submitter's Name. Address and Phone Number
The Procter & Gamble Company P.O. Box 599 Cincinnati. Ohio 45202 Phone: (513) 622-2185 Fax: (513) 622-0521 Contact person: Marlene B. Feder Preparation Date: 8/26/97
Name of the Device
Trade Name: Crest Toothbrush with MicroShield Common Name: Manual Toothbrush Classification Name: Manual Toothbrush (per 21 CFR §872.6855)
Predicate Devices
This premarket notification is claiming substantial equivalence to Crest Toothbrushes and the Butler G.U.M. Antibacterial Toothbrush (K950993).
Description of the Device
The Crest Toothbrush with MicroShield is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
Intended Use of the Device
The Crest Toothbrush with MicroShield is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatemnt is not intended to have any effect on the user.
Comparison of Technological Characteristics
The Crest Toothbrush with MicroShield is composed of handle and bristle materials identical to other Crest Toothbrushes. Like the Butler G.U.M. Antibacterial Toothbrush (K950993), the Crest Toothbrush with MicroShield contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses. Both the Butler G.U.M. Antibacterial Toothbrush and the contain an antimicrobial ingredient. While the antimicrobial agents in the two brushes are different, the antimicrobial activity of the triclosan containing brush is expected to be, at a minimum, comparable to the antimicrobial activity of chlorhexidine/zinc oxide containing brush.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest movement and flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | | | |998
Ms. Marlene B. Feder Manager, Regulatory Affairs Proctor & Gamble Company 8700 Mason-Montqomery Road Mason, Ohio 45040-9462
Re : K973236 Crest Toothbrush with Microshield Trade Name: Requlatory Class: I Product Code: EFW Dated: December 19, 1997 December 22, 1997 Received:
Dear Ms. Feder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially.equivalent_determination.assumes compliance with --the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Feder
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Alildris
Timo Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PROCTER & GAMBLE COMPANY 510(k) Notification
Manual Antimicrobial Toothbrush
510(k) Number (if known):
Device Name: Crest Toothbrush with MicroShield
Indications for use:
To remove adherent plaque and food debris from the teeth to prevent tooth decay.
To prevent the growth of bacterial between brushings to maintain the cleanliness of the toothbrush.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) All H, Office of Device Evaluation (ODE) Over-the-Counter Use V ਉਕ (Per 21 CFR 801.109)