(126 days)
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Not Found
No
The summary describes a material for constructing physical dental splints and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is primarily for diagnostic and educational purposes related to bruxism, not for actively treating or curing a medical condition.
Yes
The intended use statements (3, 4, 5, 6) explicitly state that the device is intended to "Aid the dentist in locating occlusal areas of current wear," "Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits," "Aid the dentist in differentiating between historical tooth wear and current grinding activity," and "Provide a physical record of a patient's grinding activity for a certain time period." These functions are all diagnostic in nature, providing information to help a dentist understand a patient's condition.
No
The device description explicitly states "Brux Trak™ material is intended for construction of temporary occlusal splints," indicating a physical material, not software.
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.
- Brux Trak™ Function: The intended use and device description clearly state that Brux Trak™ material is used to construct temporary occlusal splints that are placed in the mouth to protect teeth and monitor grinding habits. This is a physical device used directly on the patient, not a test performed on a sample taken from the patient.
The functions described (protecting teeth, promoting awareness, aiding in locating wear, evaluating severity, differentiating wear, providing a record) are all related to the physical interaction of the splint with the patient's teeth and mouth, not to the analysis of a biological sample.
N/A
Intended Use / Indications for Use
Brux Trak™ material is intended for construction of temporary occlusal splints.
When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following:
-
- Temporarily protect the teeth or dental work from damage due to teeth grinding
-
- Promote patient awareness of oro-myofacial habits, such as bruxism.
-
- Aid the dentist in locating occlusal areas of current wear
-
- Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits
-
- Aid the dentist in differentiating between historical tooth wear and current grinding activity. ..
-
- Provide a physical record of a patient's grinding activity for a certain time period.
Product codes
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
licensed dentist or lab technician and prescribed by a licensed dentist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved lines that resemble a person with outstretched arms, symbolizing health and well-being. The overall design is simple and recognizable, representing the department's role in promoting public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Justus Baird ·Product Manager BruxCare, L.L.C. 6331 Pineshade Lane Houston, Texas 77008
MAR 1 1 1998
Re : K974160 BruxTrak™ Trade Name: Regulatory Class: II Product Code: EBI Dated: February 13, 1998 Received: February 24, 1998
Dear Mr. Baird:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes-compliance with =============================================================================================================== the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Baird
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timc Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ of _
| 510(k) Number (if known): | K974160 |
|---|---|
| Device Name: | Brux Tsak™ material |
Indications For Use:
Brux Trak™ material is intended for construction of temporary occlusal splints.
When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following:
-
- Temporarily protect the teeth or dental work from damage due to teeth grinding
-
- Promote patient awareness of oro-myofacial habits, such as bruxism.
-
- Aid the dentist in locating occlusal areas of current wear
-
- Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits
-
- Aid the dentist in differentiating between historical tooth wear and current grinding activity. ..
-
- Provide a physical record of a patient's grinding activity for a certain time period.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Puase
(Division Sign-Off) Division of Dental. Infe and General Hospita 510/k) Number
Prescription Use મ ડ્ (Per 21 CFR 801.109)
OR
Over-The-Counter Use $\mathcal{N}^D$
(Optional Format 1-2-96)