(73 days)
- 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.
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.
This submission (K014079) for the Dr. Hays Bite Guard is a 510(k) Premarket Notification, meaning the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study demonstrating performance against specific acceptance criteria.
Therefore, the provided document does not contain a study with acceptance criteria and reported device performance in the way a clinical trial or performance study would typically be presented for novel devices or those requiring PMA. Instead, the submission relies on demonstrating that the Dr. Hays Bite Guard is substantially equivalent to existing devices.
Here's an analysis based on the information provided, highlighting why certain requested criteria are not applicable:
Summary of Acceptance Criteria and Device Performance (Not Applicable for 510(k) Substantial Equivalence)
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" defined for this new device's performance in the document, nor a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study. The "acceptance criteria" for a 510(k) is the demonstration of substantial equivalence to a predicate device.
The table below illustrates the comparison made for substantial equivalence, which serves as the basis for clearance, rather than a performance study outcome for the specific device being submitted.
| Feature | Dr. Hays Bite Guard Performance (Claimed Equivalence) | Basis for Equivalence/Predicate Device(s) |
|---|---|---|
| Intended Use & Indications for Use | Protecting against teeth grinding, bruxism, jaw clenching; short-term pain relief from muscle spasm pain due to occlusal interference; prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching. Custom made for individual. | SnoreGuard™ (K882303), Best Bite Decluder™ (K980953), NTI Clenching Suppression System (K981546). Claimed to be the Same. |
| Materials | Lexan & Elvax | SnoreGuard™ (K882303) also uses Lexan & Elvax. Other predicates use "Thermoplastic". Claimed to be the Same/Similar. |
| Design | Custom molded mouth guard | SnoreGuard™, Best Bite Decluder™, NTI System all described as "Same" design. Claimed to be the Same. |
| Prescription Device | Yes | All predicates are "Same" (Prescription). Claimed to be the Same. |
| Reusable | Yes - Single patient | All predicates are "Same" (Reusable). Claimed to be the Same. |
| Method of Disinfection | Warm water, soap & toothbrush | All predicates are "Same". Claimed to be the Same. |
Detailed Analysis of Requested Information:
-
A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. As explained above, for a 510(k) substantial equivalence submission, the "acceptance criteria" is the demonstration of similarity to predicate devices in terms of intended use, indications for use, technological characteristics (materials, design), and safety/effectiveness profiles. The table above summarizes how the Dr. Hays Bite Guard compares to its predicates, which is the basis of its "performance" for regulatory clearance in this context.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No explicit "test set" or clinical data is mentioned for the Dr. Hays Bite Guard itself in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts for a specific test set for the Dr. Hays Bite Guard is mentioned. The ground truth, in a broader sense, for the predicate devices' safety and effectiveness would have been established historically, but not for this specific submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No specific test set to adjudicate is mentioned.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a physical dental appliance, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-related metrics are irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for this specific submission. The "ground truth" for this 510(k) is the demonstrated safety and effectiveness of the predicate devices that have been legally marketed. The submission does not provide new clinical data or specific ground truth for the Dr. Hays Bite Guard.
-
The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or algorithms.
-
How the ground truth for the training set was established
- Not Applicable. There is no training set for this device submission.
Conclusion:
The K014079 submission for the Dr. Hays Bite Guard is a 510(k) Premarket Notification, which means its clearance is based on demonstrating "substantial equivalence" to one or more legally marketed predicate devices. It does not include a novel study with specific acceptance criteria that the device's performance was measured against, nor does it involve AI, imaging, or complex reader studies. The primary "study" in this context is the comparison table demonstrating the device's similarity to its predicates, SnoreGuard™ (K882303), Best Bite Decluder™ (K980953), and NTI Clenching Suppression System (K981546), across key features like indications for use, materials, and design.
{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.
{1}------------------------------------------------
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 forUse: | Protecting against teeth grinding,bruxism and jaw clenching.Short-term pain relief from musclespasm pain due to occlusalinterference.For the prevention of chronic tensionand temporal mandibular joint(TMJ) syndrome that is caused bychronic jaw clenching of theposterior mandibular and maxillaryteeth by the temporalis muscle. Thedevice is custom made for theindividual. | Snoring - sometimes usedfor Bruxism | Same | Same | Yes |
| Materials: | Lexan & Elvax | Same | Thermoplastic | Thermoplastic | Yes |
| Design: | Custom molded mouth guard | Same | Same | Same | Yes |
| PrescriptionDevice: | Yes | Same | Same | Same | Yes |
| Reusable: | Yes - Single patient | Yes | Yes | Yes | Yes |
| Method ofDisinfection: | Warm water, soap & toothbrush | Same | Same | Same | Yes |
| K-Number: | Pending | K882303 | K980953 | K981546 | Yes |
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
6
N/A