(438 days)
Not Found
No
The device description and intended use focus on the physical function of the splints as a protective barrier. There is no mention of AI/ML terms, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as treating bruxism and alleviating jaw and muscle pain, which are therapeutic claims.
No
Explanation: The device description states its use is "for the protection of teeth and restorations from the forces of Bruxism" and to "function as a protective barrier...to prevent tooth damage" and "alleviate jaw and muscle pain." It does not mention diagnosing any condition.
No
The device description explicitly states that the SomnoBrux Splints are "intraoral devices" and "consist of a custom fitted tray," indicating a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "protection of teeth and restorations from the forces of Bruxism." This is a therapeutic and protective function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is an "intraoral device" that fits over teeth. It acts as a physical barrier. This is a mechanical function within the body, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The device is clearly intended for a mechanical, protective function within the oral cavity to manage the effects of bruxism.
N/A
Intended Use / Indications for Use
The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
Product codes
MQC
Device Description
The SomnoBrux Splints are intraoral devices used for treating bruxism. They consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.
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
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
N/A
0
DEC 1 3 2011
fr
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Contact Persons: Bradley Southworth Submitter Information: SomnoMed Inc.
Address of Contact Person: 7460 Warren Parkway, Suite 190, Frisco, TX 75034, Phone 888-447-6673
Date Summary Prepared: October 28, 2011
Device Name: Various versions of SomnoBrux
Trade Name(s): SomnoBrux Splint(s)
Classification Name: Mouthguard,Prescription
Panel: Dental; Product Code: MQC
The SomnoBrux Splints are intraoral devices used for treating bruxism. They Device Description: consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.
Intended Use: The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
Substantial Equivalence and Predicate Device Information:
| Device Name | Manufacturer | 510(k) Reference |
|---|---|---|
| MYOHEALTH CLENCHING | ||
| INHIBITOR also know as Bite Soft | MCI-MYOHEALTH SYSTEMS | K040315 |
| DSG Relaxer Splint | Dental Services Group Sentage | |
| Corporation, dba. Dental | ||
| Services Group. | K022627 |
Conclusion: Based upon the comparative analysis of features, materials and design the SomnoBrux Splint, Myo Health Clenching Inhibitor, and the SomnoBrux Splints are all custom manufactured, all acrylic type devices that treat bruxism by relaxing the structure of the masticatory system. All of these splints cover posterior occlusal surfaces, whereby the Myo Health Clenching Inhibitor only covers the Maxiliary six anterior teeth. By having the dental arches discluded with these acrylic splints (anterior or posterior) prevents excessive wear of the hard dental tissue caused by the parafunctional movement known as bruxism. Any minor design differences between these various models do not affect safety and performance.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Bradley Southworth Quality Assurance Manager SomnoMed Incorporated 7460 Warren Parkway. Suite 190 Frisco. Texas 75034
Re: K102909
Trade/Device Name: SomnoBrux Splints Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: December 5, 2011 Received: December 7, 2011
Dear Mr. Southworth:
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.
DEC 1 3 2011
2
Page 2 - Mr. Southworth
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K102909
Device Name: SomnoBrux Splints
Indications for Use: The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (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 Ruser
(Division Siom-Off) Division of A . sthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K162909