(218 days)
Not Found
No
The device description and intended use focus on a physical bite plate and its mechanical function, with no mention of AI or ML technologies.
Yes.
The device's intended use includes temporary relief and treatment of Temporomandibular Joint Disorder (TMD) and bruxism, and protection of teeth and restorations from injury, which are therapeutic actions.
No
The device is described as an anterior bite plate used for protection, temporary relief, and temporary treatment of conditions like bruxism and TMD. Its function is to inhibit clenching force and protect teeth, not to diagnose any condition.
No
The device description clearly states it is a "patented anterior bite plate" which is a physical, hardware device made of plastic.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Brux-TMD QuickSplint is a physical device worn in the mouth. Its function is to protect teeth, reduce muscle tension, and alleviate pain associated with bruxism and TMD. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended uses listed are for protection, temporary relief, and temporary treatment, all of which are physical or mechanical interventions, not diagnostic procedures.
Therefore, the Brux-TMD QuickSplint falls under the category of a dental device or appliance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Protection of teeth and restorations from injury due to bruxism or clenching.
- Temporary relief of Temporo Mandibular joint Disorder (TMD) and bruxism by reducing muscle tension.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
The Brux-TMD QuickSplint is to be worn at night and removed in the morning except in the presence of severe pain in which case it may be worn during the day for limited periods as instructed by the prescriber.
The intended user includes patients diagnosed with bruxism, patients with headaches and pain related to bruxism, Patients with TMD, patients with headaches and pain related to TMD and patients who may damage teeth or dental restorations from the clenching and grinding related to bruxism activity.
In the professional office, Brux-TMD QuickSplint can be placed the same day as the office visit and following dental procedures (endodontic, oral surgery, placement of cosmetic dental prosthetics and periodontal surgery) where bruxing activity might damage the results or cause increased pain. The Brux-TMD QuickSplint is described as temporary and should be considered transitional if the patient experiences benefits.
Product codes (comma separated list FDA assigned to the subject device)
MQC
Device Description
The Brux-TMD QuickSplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid though bicuspid. It is a two-component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch.
The Brux-TMD QuickSplint is easily and quickly assembled in a provider's office for same day use by the patient.
While it is worn, the Brux-TMD QuickSplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature an opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, Temporo Mandibular joint, pericranial musculature, trigeminal innervated cranial-facial muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Provider's office (for assembly), Patient (for use); worn by patients diagnosed with bruxism, patients with headaches and pain related to bruxism, Patients with TMD, patients with headaches and pain related to TMD and patients who may damage teeth or dental restorations from the clenching and grinding related to bruxism activity.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
MigraTherapy LLC
Premarket Notification for Brux-TMD QuickSplint
NOV 222 2011
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the DEVICE is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | MigraTherapy LLC. |
|---|---|
| Address: | 4403 Manchester Avenue |
| Suite 103 | |
| Encinitas, Ca 92024 | |
| Contact Person: | Louis Kirby, MD |
| Telephone: | 602 908-1680 or 760 840-6034 |
| Fax: | 602 957-4053 |
| Preparation Date: | 29 March 2011 |
| Device Trade Name: | Brux-TMD QuickSplint |
| Common Name: | None |
| Classification Name: | Unclassified |
| Product Code: | MQC |
| Legally Marketed | |
| Predicates: | 1. MCI Clenching Inhibitor |
- Custom fabricated full occlusal coverage
- Dr. Hays Bite Guard |
テ
1
MigraTherapy LLC
510(k) Summary of Safety and Effectiveness for the Brux-TMD QuickSplint device, continued:
| Device Description: | The Brux-TMD QuickSplint is a patented anterior bite plate that
covers the upper or lower front teeth from bicuspid though bicuspid.
It is a two-component device with a hard plastic shell and a softer
compliant lining that conforms to the supporting teeth. The operator
may optionally place it on the anterior maxillary or mandibular arch. | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The Brux-TMD QuickSplint is easily and quickly assembled in a
provider's office for same day use by the patient. | | |
| | While it is worn, the Brux-TMD QuickSplint temporarily inhibits the
full force of parafunctional teeth clenching, and gives the pericranial
musculature an opportunity to relax. This reduces the muscular
tension that underlies the pain associated with many bruxism
headaches and the pain associated with TMD dysfunction. It reduces
the muscle tension in trigeminal innervated cranial-facial muscles,
thereby reducing the pain occurrence. In addition, it physically
protects the teeth from nighttime bruxing activities by covering the
dental occlusal surfaces with a durable plastic covering. | | |
| Intended Use: | 1. Protection of teeth and restorations from injury due to
bruxism or clenching.
2. Temporary relief of Temporo Mandibular joint Disorder
(TMD) and bruxism by reducing muscle tension.
3. Temporary treatment of Temporal Mandibular Disorder
(TMD) along with the relief of associated headaches and
pains. | | |
| | The Brux-TMD QuickSplint is to be worn at night and removed in
the morning except in the presence of severe pain in which case it
may be worn during the day for limited periods as instructed by the
prescriber. | | |
| | The intended user includes patients diagnosed with bruxism, patients
with headaches and pain related to bruxism, Patients with TMD,
patients with headaches and pain related to TMD and patients who
may damage teeth or dental restorations from the clenching and
grinding related to bruxism activity. | | |
| | In the professional office, Brux-TMD QuickSplint can be placed the
same day as the office visit and following dental procedures
(endodontic, oral surgery, placement of cosmetic dental prosthetics
and periodontal surgery) where bruxing activity might damage the | | |
results or cause increased pain. The Brux-TMD QuickSplint is described as temporary and should be considered transitional if the
CONFIDENTIAL
2
MigraTherapy LLC
307 3
patient experiences benefits.
These indications and patient populations are substantially the same as the predicate devices.
| | Comparison of predicate devices
Brux-TMD
QuickSplint
K11066 | MCI-
Myohealth
Clenching
inhibitor
K040315 | Full coverage,
custom fabricated
bite plate (pre-
1972 device) | Dr. Hays Bite
Guard
K014079 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------|
| Indications | Protection of teeth
and restorations
from injury due to
bruxism or clenching | Same | Same | Same |
| | Treatment of
Temporal
Mandibular Disorder
(TMD) along with
the relief of
associated headaches
and pains. | Same | Same | Same |
| | Relief of bruxism
related headaches
and pains. | Same | Same | Same |
| Regulatory | Pre-Market
Notification 510(k) | Pre-Market
Notification
510(k) | Preamendment | Pre-Market
Notification 510(k) |
| Design | Custom fitted
mouth guard | Same | Same | Same |
| Use | Nighttime | Same | Same | Same |
| Reusable | Yes | Same | Same | Same |
| Method of
disinfection | Soap and water; air
dry | Same | Same | Same |
| Materials | Polycarbonate tray;
vinyl polysiloxane
liner | Polycarbonate,
thermoplastic
liner | methacrylate acrylic | Lexan and Elvax |
| Risk of
exposure | None | None | None | None |
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name arranged in a circular fashion on the left side, with a dotted line separating the text from a stylized symbol on the right. The symbol consists of three curved lines that resemble a stylized human figure or abstract representation of health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 22 2011
Dr. Louis Kirby CEO Migra Therapy LLC 4403 Manchester Avenue, Suite 103 Encinitas, California 92024
Re: K111066
Trade/Device Name: Brux-TMD QuickSplint Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: November 10, 2011 Received: November 14, 2011
Dear Dr. Kirby:
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.
4
Page 2 - Dr. Kirby
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 /Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthon D. Aratzer
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
5
Indications for Use Statement
Intended Use:
Indications
-
- Protection of teeth and restorations from injury due to bruxism or clenching.
-
- Relief of bruxism related headaches and pains.
- Treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated 3. headaches and pains.
Prescription Use XX (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 OF NEEDED)
DRH. Office of Device Evaluation (ODE)
WILLA VOLLMER, HS for Susan Rummer 11/17/11
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K11 1066
CONFIDENTIAL
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