(55 days)
Not Found
No
The summary describes a physical mouthguard and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to reduce damage to teeth and prevent noise associated with bruxing or teeth grinding, making it a therapeutic device.
No
The device is described as a protective mouthguard for bruxism, intended to reduce damage and noise, which indicates a preventative or protective function rather than a diagnostic one.
No
The device description clearly states it is a "posterior-only occlusive mouthguard," which is a physical hardware device.
Based on the provided information, the Grind No More device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Grind No More's Function: The description clearly states that Grind No More is a physical device (a mouthguard) intended to be worn in the mouth to protect teeth from grinding. It does not involve testing any biological samples.
Therefore, Grind No More falls under the category of a physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Grind No More is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
Product codes
OBR
Device Description
Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band.
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)
DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K082301". The characters are written in a simple, clear style, making them easily readable.
510(k) SUMMARY
Placontrol, Inc.'s Grind No More
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Jonathan S. Kahan Regulatory Counsel to Placontrol, Inc. Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004
Phone: (202) 637-5794 Facsimile: (202) 637-5910
Date Prepared: August 12, 2008
Name of Device and Name/Address of Sponsor
Grind No More Placontrol, Inc. 12760 High Bluff Drive, Suite 210 San Diego, CA 92130
Common or Usual Name
Mouthguard
Classification Name
Mouthguard, Over-the-Counter
Product Code and CFR Provision
OBR, unclassified
Predicate Device
DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)
Intended Use / Indications for Use
Grind No More is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
1
Technological Characteristics
Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band. Similarly, the predicate device consists of two molar bite areas connected by a retaining band; therefore, the Grind No More device is technologically similar to the predicate device. As a safety feature to aid in device retention, each molar bite plate is grooved with vertical positioners to engage the natural anatomy of the teeth.
Substantial Equivalence
Grind No More is as safe and effective as the predicate device. Grind No More has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between Grind No More and its predicate device raise no new questions of safety or effectiveness. Thus, Grind No More is substantially equivalent.
2
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, symbolizing protection and care. The eagle is positioned above three wavy lines, which may represent the nation's waters or the flow of health services. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
U 6 2008
01
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Placontrol, Incorporated C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson LLP 555 Thirteenth Street. NW Washington, DC 20004
Re: K082301
Trade/Device Name: Grind No More Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: August 12, 2008 Received: September 18, 2008
Dear Mr. Kahan:
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
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 (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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Whomels Land, md for 11
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K082301
Device Name: Grind No More
Indications for Use:
Grind No More is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
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 Dunne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ - 14 - Page 1 of 1