← Product Code OBR · K172452 # Bruxor (K172452) _Sleep Specialties, LLC · OBR · Jan 11, 2018 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K172452 ## Device Facts - **Applicant:** Sleep Specialties, LLC - **Product Code:** OBR - **Decision Date:** Jan 11, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding. ## Device Story Bruxor is a single-piece, 'boil & bite' intraoral dental tray; fabricated from thermoplastic resin. Device is intended for home use by patients to manage bruxism. Patient heats the tray to mold it to their upper dental arch for a custom fit. During sleep, the device acts as a physical barrier between upper and lower teeth; protecting against grinding-related tooth damage and reducing grinding noise. Device is reusable and intended for single-user application. ## Clinical Evidence Bench testing only. Biocompatibility established per ISO 10993. Physical properties (melting point, density, melt flow rate) verified via ISO standards. No clinical data submitted. ## Technological Characteristics Thermoplastic resin intraoral dental tray; boil-and-bite custom-fit mechanism. Non-sterile. Biocompatibility per ISO 10993-1. Physical property testing per ISO 3146 (melting point) and ISO 1183 (density/melt flow rate). ## 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 - Custom Comfort Nightguard Version 2 ([K091660](/device/K091660.md)) ## Reference Devices - SnoreRx ([K170825](/device/K170825.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}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 11, 2018 Sleep Specialties, LLC. James Smith, Ph.D. Consultant 28591 Springfield Drive Laguna Niguel, California 92677 Re: K172452 Trade/Device Name: Bruxor™ Regulatory Class: Unclassified Product Code: OBR Dated: November 30, 2017 Received: December 4, 2017 Dear James Smith, Ph.D .: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {1}------------------------------------------------ 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) Device Name Bruxor™ Indications for Use (Describe) Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding. Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) | |--|----------------------------------------------| | | Over-The-Counter Use (21 CFR 801 Subpart C) | __ Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # SleepSpecialties ## 510(k) SUMMARY ### Submitted by: | Owner's Name: | James Fallon | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 2565 South Las Vegas Blvd., Suite #184
Las Vegas, NV 89109 | | Contact: | James S. Fallon, Managing Partner | | Telephone: | 949-702-3797 | | E-mail: | jfallon@bruxor.com | | Contact Person: | | | Name | James Smith, Ph.D. | | Address | 28591 Springfield Drive
Laguna Niguel, CA 92677 | | Telephone | 949-340-7261 | | Fax: | 949-340-7141 | | E-mail: | jrsmith00@cox.net | | Date Prepared: | January 3, 2018 | | Trade Name: | Bruxor™ | | Common Name: | Mouthguard | | Classification Name: | Mouthguard, Over-The-Counter | | Device Class: | Unclassified | | Product Code: | OBR | | Predicate Device: | Custom Comfort Nightguard Version 2
(Dentek Oral Care, Inc.) | | Predicate 510(k) #: | K091660 | | Reference Device: | SnoreRx (K170825; Apnea Sciences Corporation) | | Device Description: | The Bruxor mouthguard consists of a single 'boil & bite'
tray, fabricated from a thermoplastic resin, that fits over the
upper dental arch. | | Intended Use: | Bruxor™ is intended to protect teeth and reduce the damage
caused by bruxing, or night time teeth grinding, and to
prevent the noise associated with bruxing and grinding. | | Technology Comparison: | The technical characteristics of Bruxor are substantially
equivalent to the predicate device. The table below compares
the technological aspects of the new and predicate device. | {4}------------------------------------------------ # SleepSpecialties | Subject Area | Bruxor | Predicate | Differences | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Product Code | ORB | ORB | | | Product Classification | Unclassified | Unclassified | | | Classification Name | Mouthguard, OTC | Mouthguard, OTC | | | Proprietary Name | Bruxor™ | Custom Comfort
Nightguard Version 2 | | | Technological Features | Intraoral dental tray | Intraoral dental tray | | | Intended Use | Aids in the reduction of
tooth damage and noise
due to bruxing and
grinding | Aids in the reduction of
tooth damage and noise
due to bruxing and
grinding | | | Indications for Use | Bruxor™ is intended to
protect teeth and reduce
the damage caused by
bruxing, or night time
teeth grinding, and to
prevent the noise
associated with bruxing
and grinding. | The Custom Comfort
Nightguard Version 2 is
indicated for use for
protection against
bruxism or nighttime
teeth grinding. It is
intended to reduce
damage to the teeth and
to prevent the noise
associated with bruxing
or grinding. | Minor
differences in
phrasing,
however the
meaning is
equivalent. | | Materials | - Formable material
(thermoplastic resin) | - Formable tray
(thermoplastic resin)
– Non-formable base
- Non-formable fitting
tray | The Bruxor
uses a different
thermoplastic
resin and does
not include a
non-formable
base or fitting
tray. | | Desirable
Characteristics | Home use, heat sensitive /
moldable, custom fitted | Home use, heat sensitive
/ moldable, custom fitted | | | Specifications: | – Custom-fitted intraoral
device
– Covers the upper teeth
- Reusable, single-user | – Custom-fitted intraoral
device
– Covers the upper teeth
- Reusable, single-user | | | Sterility | Non-sterile | Non-sterile | | | Biocompatibility | ISO 10993-1 | ISO 10993-1 | | | Anatomical Sites | Intraoral, during sleep | Intraoral, during sleep | | | Human Factors | Standard 'boil-and-bite'
fitting | Standard 'boil-and-bite'
fitting | | | Compatibility with the
environment & other
devices | Label warnings against use
with certain other dental
accessories | Label warnings against
use with certain other
dental accessories | | {5}------------------------------------------------ ## SleepSpecialties Nonclinical Testing Biocompatibility was established in accordance with ISO 10993 requirements. Device material physical properties included melting point (ISO 3146), density (ISO 1183), and melt flow rate (ISO 1183). Biocompatibility and physical properties of the thermoplastic resin material were previously established through the reference device (K170825). Additional test reports were therefore not submitted as a part of this filing. Conclusion of Comparison: Based upon the technological characteristics, materials of construction, and general design considerations, Bruxor has been determined to be substantially equivalent to its predicate device. --- **Source:** [https://fda.innolitics.com/device/K172452](https://fda.innolitics.com/device/K172452) **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