(348 days)
Not Found
No
The summary describes a physical mouth guard with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The intended use is to protect against grinding and clenching, which is a prophylactic or protective function, not a therapeutic treatment for a disease or condition.
No
The device description states its intended use is to protect against grinding and clenching by providing a physical barrier, not to diagnose a condition.
No
The device description clearly states it is an oral appliance made of physical materials (polysulfone and polycaprolactone), indicating it is a hardware device, not software-only.
Based on the provided information, the GrindGUARDN is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect against grinding and clenching." This is a mechanical function related to the physical structure of the mouth and teeth.
- Device Description: The device is a physical oral appliance made of specific materials designed to be molded to the teeth.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVDs are specifically designed to perform tests in vitro (outside the body) on biological samples to aid in diagnosis, monitoring, or screening. The GrindGUARDN's function is purely mechanical and protective within the oral cavity.
N/A
Intended Use / Indications for Use
The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.
Product codes
MQC
Device Description
The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower 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 the inner, moldable layer consists of polycaprolactone.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K073220, K010876, K962516, K900389
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 3 1 2009
GrindGUARDN
6.0 510(K) SUMMARY
| Manufacturer | Grind Guard Technologies LLC |
|---|---|
| Contact Name | Dr. Joseph Pelerin |
| Postal Address | 4498 Klais Dr. |
| Clarkston MI 48348 | |
| Phone Number | 248-391-1625 |
| Fax | 248-391-1727 |
| contact@advantagedentlinc.com | |
| Title | President and CEO |
| Date | September 15,2008 |
| Proprietary Name | GrindGUARDN |
|---|---|
| Common Name | Mouthguard |
| Classification Name | Mouthguard, Prescription |
| Classification Code | MQC |
Predicate Devices
Substantial equivalence is being claimed to:
- The Doctor's Nightguard Advanced Comfort (K073220)
- . NTI Tension Suppression System (K010876)
- TAP- anti-snoring device ( formerly Quiet Knight) (K962516) .
- . Temporary Crown Matrix Buttons (K900389)
Description of Device
The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower 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 the inner, moldable layer consists of polycaprolactone.
Intended Use
The GrindGUARD, is a mouth guard intended to protect against grinding and clenching.
Traditional 510 (k) Submission
. -
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 81 2009
Grind Guard Technologies, LLC Mr. Bill McLain Principal Consultant Keystone Regulatory Services, LLC 342 East Main Street, Suite 207 Leola, Pennsylvania 17540
Re: K082723
Trade/Device Name: GrindGUARDN Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: August 17, 2009 Received: August 20, 2009
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.
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.
2
Page - 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reporta Problem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
GrindGUARDN
Grind Guard Technologies, LLC
SECTION 5. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indications for Use:
GrindGUARDN
The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________