← Product Code MQC · K040315 # MYOHEALTH CLENCHING INHIBITOR (K040315) _Mci-Myohealth Systems · MQC · Aug 27, 2004 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K040315 ## Device Facts - **Applicant:** Mci-Myohealth Systems - **Product Code:** MQC - **Decision Date:** Aug 27, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use 1. Protection of teeth and restorations from the forces of bruxism. 2. For the prevention of TMJ syndrome through reduction of the prevention of TMJ syndroptivity trigeminally innervated muscular activity. ## Device Story MCI Clenching Inhibitor is a custom-fabricated, intraoral occlusal stent; designed to span six teeth (upper cuspid to cuspid). Device features thermoplastic acrylic lining for retention. Operates as an anterior bite stop; disrupts pericranial musculature activity by modifying contact of opposing teeth; inhibits masticatory musculature. Used by patients under professional diagnosis to manage bruxism and temporal mandibular disorders (TMD). Larger size compared to some anterior devices reduces risk of inhalation or swallowing. Clinical benefit includes protection of dental structures and reduction of TMD symptoms. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device. ## Technological Characteristics Custom-fabricated intraoral occlusal stent; thermoplastic acrylic material; anterior bite stop design; spans 6 teeth (upper cuspid to cuspid). ## Predicate Devices - NTI Clenching Suppression System ([K981546](/device/K981546.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}------------------------------------------------ AUG 2 7 2004 K040315 ## MCI Clenching Inhibitor 510(k) Summary of Safety and Effectiveness Device Generic Name Occlusal Stent Device Trade Name MCI Clenching Inhibitor Regulation Number and Name 21 CFR 872.5570 Device, Jaw Positioning Product Code LQZ Panel Code Dental Applicant Name and Address MCI-Myohealth Systems 6B Inga Parade, Mt. Martha VIC 3934 AUSTRALIA Contact Information Dave Balding Consultant 26552 Tampico Place Mission Viejo CA 92691 USA Phone: (949) 412-0619 or (949) 916-2663 ## Device Description Description The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by The Myoncardi Cleneining minoner an Aparanting contact of opposing providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders. The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals. The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention. (949) 916-2663 Fax: {1}------------------------------------------------ K040315 ## Comparison to Predicate Device | Attribute | Myohealth Clenching
Inhibitor | Predicate
(NTI Clenching Suppression
System, K981546) | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | Protection of teeth and
restorations from the forces of
bruxism.
Recovery from temporal
mandibular disease (TMD) in
which bruxism is a
contributing factor. | For the prevention of chronic
tension and temporal joint
syndrome that is caused by
chronic clenching of the
posterior mandibular and
maxillary teeth by the
temporalis muscle. | | Method of manufacture | Custom fabricated | Custom fabricated | | Single patient, intraoral
device | yes | yes | | Material | Thermoplastic acrylic | Thermoplastic acrylic | | Method of
action/intended use. | An anterior bite stop that
inhibits masticatory
musculature. | An anterior bite stop that
inhibits masticatory
musculature. | | Risk of material
exposure | None | None | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. JUL 1 7 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MCI-Myohealth Systems C/O Mr. David Balding Consultant and Authorized Contact David Balding 26552 Tampico Place Mission Viejo, California 92691 Re: K040315 Trade/Device Name: MCI-Myohealth Clenching Inhibitor Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: August 19, 2004 Received: August 23, 2004 Dear Mr. Balding: This letter corrects our substantially equivalent letter of August 27, 2004. 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 (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. Balding 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); 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. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Suette Y. M. chein Oud. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K040315 ## Indications for Use 510(k) Number (if known): K040315 MCI-MyoHealth Clenching Inhibitor Device Name: Indications For Use: 1. Protection of teeth and restorations from the forces of bruxism. 2. For the prevention of TMJ syndrome through reduction of the prevention of TMJ syndroptivity trigeminally innervated muscular activity. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Rino (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division of Anesthesiology, General Devices Division of Anesthoology. Infection Control, Dental Devices 510(k) Number. --- **Source:** [https://fda.innolitics.com/device/K040315](https://fda.innolitics.com/device/K040315) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com