(27 days)
No
The device description and intended use focus on a physical mouthguard for bruxism, with no mention of AI/ML terms, data processing, or performance studies related to algorithmic analysis.
Yes.
The device is intended to reduce damage to the teeth and prevent noise associated with bruxing or grinding, which are therapeutic effects.
No
The device is indicated for protection against bruxism and teeth grinding, and to reduce damage and noise associated with these conditions. It does not state that it diagnoses any condition, only prevents damage from an existing one.
No
The device description clearly states it is a physical mouthguard with specific anatomical features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism (teeth grinding) and to reduce damage and noise associated with it. This is a physical, mechanical function within the mouth.
- Device Description: The device is a mouthguard, a physical appliance worn in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on biological samples to gain information about a person's health status. This device is a physical barrier and protective appliance.
N/A
Intended Use / Indications for Use
Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Product codes
OBR
Device Description
Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate.
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
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)
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
Not Found
N/A
0
K09 4020
510(k) SUMMARY
Ranir, LLC's Grind No More Generation II
JAN 2 5 2010
: |
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Jonathan S. Kahan Regulatory Counsel to Ranir, LLC Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004
| Phone: | (202) 637-5794 |
|---|---|
| Facsimile: | (202) 637-5910 |
Date Prepared: December 10, 2009
Name of Device and Name/Address of Sponsor
Grind No More Generation II
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512
(616) 698-8880 Phone: Facsimile: (616) 656-7650
Common or Usual Name
Mouthguard
Classification Name
Mouthguard, Over-the-Counter
Classification Product Code
OBR
1
Predicate Devices
Ranir, LLC's Grind No More 2 (K091175) Ranir, LLC's Rest Assured Nite Protector (K063229)
Purpose of the Special 510(k) notice.
The Grind No More Generation II is a modification to Ranir's Grind No More 2 (K091175).
Intended Use
Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Technological Characteristics
Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate. However, there are multiple FDA cleared mouthguards that incorporate both anterior and posterior occlusion, such as the predicate Rest Assured. Therefore, the Grind No More Generation II is technologically similar to the predicate devices.
Substantial Equivalence
Grind No More Generation II is as safe and effective as the predicate devices. Grind No More Generation II has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More Generation II and the predicate devices raise no new questions of safety or effectiveness. Thus, the Grind No More Generation II is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 9 5 2010
Ranir LLC C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan and Hartson LLP 555 Thirteenth Street, N.W. Washington, District of Columbia 20004
Re: K094020
Trade/Device Name: Grind No More Generation II Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: OBR Dated: December 29, 2009 Received: December 29, 2009
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 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
Page 2 - Mr. Kahan
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 (OS) 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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):
Device Name: Grind No More Generation II
Indications for Use:
The Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Prescription Use (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr. K.P. Mulay
(Division Sign-Off) ( (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: