(73 days)
Not Found
No
The description focuses on the physical materials and custom molding process of a bite guard, with no mention of AI or ML technologies.
Yes
The device is described as assisting in the "treatment of occlusal disorders" and is intended for "short-term pain relief" as well as "prevention of chronic tension and temporal mandibular joint (TMJ) syndrome," which are therapeutic applications.
No
The device is described as assisting in the treatment of occlusal disorders and is used for protection and pain relief. There is no mention of it being used to diagnose or identify a disease or condition.
No
The device description explicitly states the device is comprised of a "thin horseshoe shaped plastic (polycarbonate, Lexan) tray filled with a thermoplastic agent (Elvax)," indicating it is a physical, hardware-based device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Dr. Hays Bite Guard is a physical device that is placed in the mouth to treat mechanical issues related to teeth grinding and jaw clenching. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a physical intervention to protect teeth and relieve pain caused by mechanical forces, not to diagnose or monitor a medical condition through laboratory analysis.
- Device Description: The description details the physical materials and how the device is fitted, not how it interacts with or analyzes biological specimens.
Therefore, based on the provided information, the Dr. Hays Bite Guard falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Protecting against teeth grinding, bruxism and jaw clenching. .
- Short-term pain relief from muscle spasm pain due to occlusal . interference.
- For the prevention of chronic tension and temporal mandibular . joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
Product codes
LQZ, MQC
Device Description
The Dr. Hays Bite Guard is designed to assist in the treatment of occlusal disorders resulting in teeth grinding, jaw clenching, and mandibular muscle spasm. The device is comprised of a thin horseshoe shaped plastic (polycarbonate, Lexan) tray filled with a thermoplastic agent (Elvax). The device is supplied to health care practioners to heat, mold, and otherwise custom fit and trim each device to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular and maxillary teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care practioners
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
Not Found
N/A
0
10(k) Premarket Notification Summary of Safety and Effectiveness Information
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807,92
1. Device Name:
FEB 2 2 2002
Trade Name: Dr. Hays Bite Guard Common Name: Night Guard Classification Name: Device, Jaw Repositioning
2. Establishment Name & Registration Number:
Name: Inventive Resource, Inc. Number: Pending
3. Classification:
Unclassified Device
Product Code(s): LQZ Device Class: unclassified Classification Panel: Anesthesia Devices Panel & Dental Device Panel
Contact Person: 4.
Mr. John A. Paoluccio Inventive Resources, Inc. 5038 Salida Blvd. Salida, CA 95368 209.545.2616 - 209.545.3533 - fax
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 925.356.2640 / 925.356.2654 FAX
ડ. Description of the Device:
The Dr. Hays Bite Guard is designed to assist in the treatment of occlusal disorders resulting in teeth grinding, jaw clenching, and mandibular muscle spasm. The device is comprised of a thin horseshoe shaped plastic (polycarbonate, Lexan) tray filled with a thermoplastic agent (Elvax). The device is supplied to health care practioners to heat, mold, and otherwise custom fit and trim each device to the patient. Materials: the Dr. Hays Bite Guard is made of Lexan and Elvax, the same materials as the Snore Guard device, cleared under K882303.
The device is supplied Non-Sterile.
The device is packaged in "clean only" condition but is free of manufacturing debris and/or residues. Components are inspected after processing to evaluate and document the removal of manufacturing residue and debris. However, it is recommended that the device be removed from its shipping and packing materials and washed with warm soap and water before use. The device may not be autoclaved.
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The Dr. Hays Bite Guard is non-sterile and must be cleaned and sanitized before first and all Sanitizing. subsequent uses. Wash the device thoroughly with hot water using a typical commercial detergent or antibacterial soap. Rinse completely in running warm tap water. Allow to air dry and return the device to its case. See Appendix I for complete instructions.
Packaging. Materials used in the packaging of the device are typical injection molded plastic boxes. Carton and shippers are made from appropriate paper based products.
Storage. The device should be stored clean and dry. The location should be at the bedside or bathroom on in locations where ambient temperatures do not exceed 130 degrees F.
6. Comparison to Predicate Device(s):
Dr. Hays Bite Guard may be directly contrasted with the following equivalent devices:
Summary Basis for Equivalence and Comparison Table:
Based on the available information concerning the referenced comparison devices are similar in that:
The devices have the same intended use and indications for use. The devices are made of the same basic materials. The devices have a similar design, form and function.
The referenced comparison devices demonstrate that the Dr. Hays Bite Guard is substantially equivalent . The table on the following page compares the available legally marketed devices.
| Comparison Table: | ||||
|---|---|---|---|---|
| ------------------- | -- | -- | -- | -- |
| FEATURE | Dr. Hays Bite Guard | Snore Guard | Best Bite | NTI System | SE? |
|---|---|---|---|---|---|
| Indications for | |||||
| Use: | Protecting against teeth grinding, | ||||
| bruxism and jaw clenching. | |||||
| Short-term pain relief from muscle | |||||
| spasm pain due to occlusal | |||||
| interference. | |||||
| For the prevention of chronic tension | |||||
| and temporal mandibular joint | |||||
| (TMJ) syndrome that is caused by | |||||
| chronic jaw clenching of the | |||||
| posterior mandibular and maxillary | |||||
| teeth by the temporalis muscle. The | |||||
| device is custom made for the | |||||
| individual. | Snoring - sometimes used | ||||
| for Bruxism | Same | Same | Yes | ||
| Materials: | Lexan & Elvax | Same | Thermoplastic | Thermoplastic | Yes |
| Design: | Custom molded mouth guard | Same | Same | Same | Yes |
| Prescription | |||||
| Device: | Yes | Same | Same | Same | Yes |
| Reusable: | Yes - Single patient | Yes | Yes | Yes | Yes |
| Method of | |||||
| Disinfection: | Warm water, soap & toothbrush | Same | Same | Same | Yes |
| K-Number: | Pending | K882303 | K980953 | K981546 | Yes |
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other, with flowing lines beneath them.
JUL 1 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inventive Resources, Incorporated C/O Mr. David W. Schlerf Buckman Company 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K014079 Trade/Device Name: Dr. Hayes Bite Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: November 9, 2001 Received: December 11, 2001
Dear Mr. Schlerf:
This letter corrects our substantially equivalent letter of February 22, 2002.
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 (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.
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.
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Page 2 - Mr. Schlerf
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); 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.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Suite Y. Michael DMD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number
Dr. Hays Bite Guard Device Name:
Indications For Use:
- Protecting against teeth grinding, bruxism and jaw clenching. .
- Short-term pain relief from muscle spasm pain due to occlusal . interference.
- For the prevention of chronic tension and temporal mandibular . joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Susan Runar |
| Division of Dental, Infection Control, and General Hospital Devices | |
| F10(k) Number | 1501409 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional format 1-2-96) |
bite.doc
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