(119 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is a physical mouth guard with a moldable material.
No
The device is intended to protect against grinding and clenching, which aligns with the prophylactic function of a mouthguard rather than the treatment or diagnosis typically associated with a therapeutic device.
No
The device is described as a mouth guard intended to protect against grinding and clenching, and its function involves physical molding to the teeth to prevent night grinding. There is no mention of the device being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly outlines a physical oral appliance made of polysulfone and polycaprolactone, requiring molding to the patient's teeth. This is a hardware device, not software.
Based on the provided information, the GrindGuardN is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "protect against grinding and clenching." This is a therapeutic or protective function, not a diagnostic one.
- Device Description: The device is a physical mouth guard designed to be worn in the mouth to prevent teeth grinding. It does not involve any testing of biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to detect, measure, or analyze any substances or markers in the body to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The GrindGuardN does not fit this description.
N/A
Intended Use / Indications for Use
The GrindGuardN is a mouth guard intended to protect against grinding and clenching.
Product codes
OBR
Device Description
The GrindGuard® is an oral appliance consisting of a thin exterior tray (shell) that covers approximately half of the lower or upper arch, with a dome shape protrusion (in the center of the device), to be situated over the central incisors and an internal layer which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and is formed by injection molding. The inner, formable layer consists of polycaprolactone. The GrindGuard® is designed to prevent night grinding.
After a brief submersion in water which has been heated in the microwave the thermoplastic liner becomes translucent and formable. The patient centers the device over his/her lower front teeth and bites until pressure is felt on upper and lower two front teeth. Gentle pressure is applied to the ends of the GrindGuard4 for approximately 2 minutes in order to set the thermoplastic material. The rigid polysulfone outer tray helps the softer material maintain shape and conformity with the teeth while forming the device.
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
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)
No non-clinical testing was performed for this submission.
No clinical testing was performed in association with this submission.
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
Not Found
N/A
0
JAN 2 3 2014
5 510(k) Summary
Submission Correspondent and Owner 5.1
Submission Correspondent
Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Phone: (717) 656-9656 Fax: (717) 656-3434 Email: bill.mclain@keystoneregulatory.com
Sponsor (Owner)
Grind Guard Technologies, LLC 4498 Klais Dr. Clarkston, MI 48348 Phone: 248-499-5519 Fax: 248-391-1728 Email: info@grindguardn.com
5.2 Date Summary Prepared
September 24, 2013
5.3 Device Trade Name
GrindGuardN
5.4 Device common name
Mouthguard. Antibruxing night guard.
Device classification name 5.5
Mouthguard, Over-The-Counter, OBR - Unclassified
5
1
Legally Marketed Device To Which The Device Is 5.6 Substantially Equivalent
Grindguard Technologies - GrindGuard® (RX) - K082723 SmartGuard, Inc. - SmartGuard Night Guard - K123161
5.7 Description Of The Device
The GrindGuard® is an oral appliance consisting of a thin exterior tray (shell) that covers approximately half of the lower or upper arch, with a dome shape protrusion (in the center of the device), to be situated over the central incisors and an internal layer which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and is formed by injection molding. The inner, formable layer consists of polycaprolactone. The GrindGuard® is designed to prevent night grinding.
After a brief submersion in water which has been heated in the microwave the thermoplastic liner becomes translucent and formable. The patient centers the device over his/her lower front teeth and bites until pressure is felt on upper and lower two front teeth. Gentle pressure is applied to the ends of the GrindGuard4 for approximately 2 minutes in order to set the thermoplastic material. The rigid polysulfone outer tray helps the softer material maintain shape and conformity with the teeth while forming the device.
The GrindGuard® is indicated for use as a mouth guard intended to protect. against grinding and clenching.
5.8 Technological Characteristics
The GrindGuard® has identical technical characteristics as the predicate devices.
Non-Clinical Testing 5.9
No non-clinical testing was performed for this submission.
Biocompatibility 5.10
Since the materials and methods of construction are identical to the K082723 predicate device, no additional biocompatibility testing was conducted.
б
2
5.11 Clinical Testing
No clinical testing was performed in association with this submission.
5.12 Conclusions
;
The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.
7
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2014
Grind Guard Technologies, LLC C/O Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540
Re: K133037
Trade/Device Name: GrindGuardN Regulation Number: Unclassified Regulation Name: Mouthguard, Over-The-Counter Regulatory Class: Unclassified Product Code: OBR Dated: October 23, 2013 Received: October 25, 2013
Dear Mr. McLain:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. McLain
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The letters are arranged in two lines, with "Kwame" on the first line and "Ulmer-S" on the second line. Behind the name, there is a complex, geometric design that appears to be made up of small, interconnected lines and shapes. The design adds a textured background to the text, making it stand out.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name GrindGuardN
Indications for Use (Describe)
The GrindGuardN is a mouth guard intended to protect against grinding and clenching.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
. Runne
2014.01.23 07:57:31 "-05 00" Scouters CROLL LES 41 Jul
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (6/13)
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