(16 days)
No
The summary describes a physical dental device and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is intended for protection against bruxism, reducing damage to teeth, and preventing noise. While it addresses a health issue, it does not involve treating or curing a disease, alleviating symptoms, or restoring function in a way typically associated with therapeutic devices in a broader medical context. It acts more as a protective barrier or preventative measure.
No
The device is indicated for protection against bruxism and to reduce damage to teeth, not for diagnosing bruxism or any other medical condition. It's a protective device, not a diagnostic one.
No
The device description explicitly states it is a "posterior-only occlusive nightguard, consisting of two molar bite plates connected by a buccal retention band," which are physical components, not software.
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 and reducing damage to teeth. This is a physical intervention applied directly to the patient's mouth.
- Device Description: The device is a physical nightguard.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
This device falls under the category of a medical device, specifically a dental device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are 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 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band. Similarly, the predicate devices consist of two molar bite areas connected by a retaining band; therefore, the Grind No More 2 and Grind No More 3 devices are technologically similar to the predicate devices. As with the predicate Grind No More 1, the molar bitc plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention.
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
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
510(k) SUMMARY
Ranir, LLC's Grind No More Version 2 and Grind No More Version 3
MAY - 8 2009
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: April 22, 2009
Name of Device and Name/Address of Sponsor
Grind No More Version 2 and Grind No More Version 3
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 (616) 698-8880 Phone: Facsimile: (616) 656-7650
Common or Usual Name
Nightguard
Classification Name
ﺮ
Mouthguard, Over-the-Counter
Classification Product Code
OBR
1
Predicate Devices
Placontrol, Inc.'s Grind No More (K082301) DenTek Oral Care, Inc.'s Comfort Fit NightGuard (K072147)
Purpose of the Special 510(k) notice.
The Grind No More Version 2 and Grind No More Version 3 are modifications to Placontrol's Grind No More (K082301).
Intended Use
Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Technological Characteristics
Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band. Similarly, the predicate devices consist of two molar bite areas connected by a retaining band; therefore, the Grind No More 2 and Grind No More 3 devices are technologically similar to the predicate devices. As with the predicate Grind No More 1, the molar bitc plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention.
Substantial Equivalence
Grind No More 2 and Grind No More 3 are as safe and effective as the predicate devices. Grind No More 2 and Grind No More 3 have 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 2, Grind No More 3, and the predicate devices raise no new questions of safety or effectiveness. Thus, Grind No More 2 and Grind No More 3 are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K091175
Trade/Device Name: Grind No More Version 2 and Grind No More Version 3 Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: OBR Dated: April 22, 2009 Received: April 22, 2009
Dear Mr. Kahan:
We have reviewed your Scction 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 cquivalence 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 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 yours.
Susan Runner, D.D.S., M.A.
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
4
K0911:75
Indications for Use Statement
510(k) Number (if known):
Device Name: Grind No More Version 2 and Grind No More Version 3
Indications for Use:
The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are 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)
Susan Gunser
: Ion Sign-Off) .slon of Anesthesiology, General Hospital nection Control, Dental Devices
510(k) Number