(150 days)
No
The summary describes a simple thermoplastic mouthguard with no mention of AI/ML capabilities or data processing.
Yes
The device is intended to "protect teeth and reduce the damage caused by bruxing, or night time teeth grinding," which indicates a therapeutic purpose.
No
Explanation: The Bruxor™ device is intended to protect teeth and reduce damage from bruxing, and to prevent associated noise. Its function is to mitigate rather than diagnose a condition.
No
The device description explicitly states it is a "single 'boil & bite' tray, fabricated from a thermoplastic resin," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Bruxor's Function: The Bruxor mouthguard is a physical device that is placed inside the mouth to protect teeth and reduce the effects of bruxing. It does not involve the analysis of any bodily specimens.
The provided information clearly describes a physical device for mechanical protection, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The 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.
Product codes
OBR
Device Description
The Bruxor mouthguard consists of a single 'boil & bite' tray, fabricated from a thermoplastic resin, that fits over the upper dental arch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral, during sleep
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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)
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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. |
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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.