← Product Code OBR · K091175 # GRIND NO MORE VERSION 2 AND 3 (K091175) _Ranir, LLC · OBR · May 8, 2009 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K091175 ## Device Facts - **Applicant:** Ranir, LLC - **Product Code:** OBR - **Decision Date:** May 8, 2009 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## 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. ## Device Story Posterior-only occlusive nightguard; consists of two molar bite plates connected by a buccal retention band. Molar bite plates feature grooves with vertical positioners to engage natural tooth anatomy for retention. Used by patients at home for nighttime protection against bruxism. Device acts as a physical barrier between teeth to prevent grinding damage and noise. ## Clinical Evidence No clinical data; substantial equivalence based on technological comparison to predicate devices. ## Technological Characteristics Posterior-only occlusive nightguard; two molar bite plates connected by a buccal retention band; molar plates include grooved vertical positioners for retention. ## Regulatory Identification To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. ## Predicate Devices - Grind No More ([K082301](/device/K082301.md)) - Comfort Fit NightGuard ([K072147](/device/K072147.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K091175 ### 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 --- **Source:** [https://fda.innolitics.com/device/K091175](https://fda.innolitics.com/device/K091175) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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