(264 days)
The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.
This document is an FDA 510(k) Premarket Notification for the "Goyo Mouthpiece S", a device indicated for protection against bruxism or nighttime teeth grinding. The submission aims to demonstrate substantial equivalence to a predicate device (K133423, Rest Assured® Extra Comfort Nite Protector / Ranir, LLC).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
No clinical performance data was provided for this device. The submission relies on non-clinical performance data (biocompatibility and mechanical testing) to demonstrate substantial equivalence to the predicate device, stating that the differences do not affect safety and effectiveness. Therefore, the questions related to clinical study design, sample size, expert involvement, and ground truth for a clinical test set are not applicable here.
Device Performance and Acceptance Criteria Breakdown:
The acceptance criteria for this device are implicitly tied to demonstrating that its performance characteristics are comparable to the predicate device and that it is safe and effective for its indicated use. The studies performed are non-clinical (biocompatibility and mechanical testing).
No specific quantitative acceptance criteria targets (e.g., "accuracy > 90%") are stated for the Goyo Mouthpiece S in this document. Instead, the document states that "All test results for appearance, dimensions, Shore A hardness, tensile strength, tear strength, water sorption, and water solubility were similar to that of the predicate device." and that "The performance characteristics of the subject device are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness."
Here's a table summarizing the reported device performance where applicable, compared to the predicate:
| Acceptance Criteria (Implicit) | Reported Device Performance (Goyo Mouthpiece S) | Predicate Device Performance (K133423) | Conclusion / Comparison |
|---|---|---|---|
| Material Composition | Ethylene Vinyl Acetate Copolymer [Elvax] | Ethylene Vinyl Acetate Copolymer [Elvax and Elvaloy] | Similarities: Both are dental thermoplastic polymers with similar characteristics. Difference (Elvaloy presence in predicate) does not affect safety and effectiveness. |
| Biocompatibility (per ISO 10993-1, battery of tests) | Biocompatible for Cytotoxicity, Sensitization, and Irritation | Biocompatible according to ISO 10993-1 | No difference. Both meet ISO 10993-1. |
| Appearance | Not explicitly detailed, but tested. | Not explicitly detailed, but tested. | "Similar" to predicate. |
| Dimensions (Width) | Avg. 70.38mm | Avg. 66.6mm | Similarities: Subject device is larger but "thinner" and does not introduce additional safety/efficacy concerns. Mechanical testing showed similarity. |
| Dimensions (Length) | Avg. 47.32mm | Avg. 43.72mm | Similarities: Subject device is larger but "thinner" and does not introduce additional safety/efficacy concerns. Mechanical testing showed similarity. |
| Shore A Hardness | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Tensile Strength | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Tear Strength | Avg. 60.3 ± 4.13 N | Avg. 58.6 ± 4.92 N | Similarities: Very close numerical values, falling within expected variation. |
| Water Sorption | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Water Solubility | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
Study Details (Non-Clinical Performance Data):
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of samples used for each mechanical test (e.g., 'n=' for tensile strength, tear strength, etc.). It only provides average values and standard deviations for tear strength.
- Data Provenance: The tests were performed to support substantial equivalence to a predicate device. The location of the testing laboratories is not explicitly stated, but the manufacturer (DIMEDIKOREA) is based in South Korea, and the correspondent (SMB Korea) is also in South Korea. The data would be considered retrospective as it was collected to support the premarket notification.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on objective physical and chemical property testing (biocompatibility and mechanical testing) rather than expert-derived ground truth from interpreting medical images or clinical outcomes.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to human assessment and consensus, which is not part of the non-clinical testing performed.
-
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 mouthguard, not an AI-powered diagnostic or assistive tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Test Standards: The "ground truth" for the non-clinical tests (biocompatibility, mechanical properties) is adherence to recognized international standards (e.g., ISO 10993-1 for biocompatibility) and comparison to the known characteristics of the legally marketed predicate device.
-
The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.
-
How the ground truth for the training set was established:
- Not applicable. (See point 7).
Summary of Approach:
The FDA 510(k) submission for the Goyo Mouthpiece S relied on a direct comparison of the device's technical characteristics and non-clinical performance data (biocompatibility and mechanical properties) to a legally marketed predicate device (K133423). The argument for substantial equivalence is based on the premise that any minor differences in material composition or dimensions do not raise new questions of safety or effectiveness, as demonstrated by the comparable performance in standard physical and chemical tests. Clinical performance data was explicitly stated as not having been provided, indicating that the non-clinical data was deemed sufficient to establish substantial equivalence for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2024
Dimedikorea % Kyung-Hwan Kim Representative Consultant SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu Seoul, 07071 SOUTH KOREA
Re: K232238
Trade/Device Name: Goyo Mouthpiece S Regulatory Class: Unclassified Product Code: OBR Dated: March 14, 2024 Received: March 14, 2024
Dear Kyung-Hwan Kim:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232238
Device Name Goyo Mouthpiece S
Indications for Use (Describe)
The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" in a bold, sans-serif font, followed by the word "Korea" in a lighter, sans-serif font. A curved line underlines the letters "SMB" and extends slightly beyond the "B". Below the logo is the text "A Member of the Consulting Expert Group" in a smaller, sans-serif font.
510(k) Summary
I. SUBMISSION SPONSOR
DIMEDIKOREA Rm.201, 1, Mandeok 3-ro, 16beon-gil, Buk-gu, Busan, Republic of Korea Office number: +82-507-1394-6232 Fax number: +82-51-343-8906 Contact Person: Mr. Dong-hun Lee, PRESIDENT
II. SUBMISSION CORRESPONDENT
SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +82-2-6241-9001 Contact: Mr. Kyung-hwan Kim, Representative Consultant, QA Email: info@smbkorea.com
III. DATE PREPARED
April 17, 2024
IV. DEVICE
| Trade or Proprietary Name: | Goyo Mouthpiece S |
|---|---|
| Common or Usual Name: | Mouthguard, Over-The-Counter |
| Classification Name: | Unclassified, Pre-Amendment |
| Regulatory Class: | Unclassified |
| Product Code: | OBR |
| Classification Panel: | Dental |
V. PREDICATE DEVICE
K133423, Rest Assured® Extra Comfort Nite Protector / Ranir, LLC
No reference devices were used in this submission.
VI. DEVICE DESCRIPTION
The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by
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Image /page/5/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" in a bold, sans-serif font, followed by the word "Korea" in a similar font but slightly smaller size. A curved line extends from under the "S" in SMB, underlining the entire logo. Below the logo, in a smaller, lighter gray font, is the text "A Member of the Consulting Expert Group."
a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.
VII. INDICATION FOR USE
The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE
The indications for use and mechanism of action of the subject device are identical to the predicate device and supports a determination of substantial equivalence.
So that, the subject device performed testing as that of each predicate device. All test results for appearance, dimensions, Shore A hardness, tensile strength, tear strength, water sorption, and water solubility were similar to that of the predicate device.
The performance characteristics of the subject device are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness.
Goyo Mouthpiece S has the same intended use/technical characteristics as the predicate, a soft, formable ethylene-vinyl acetate copolymer resin that, by way of the 'boil and bite' method, is fitted to an individual. Both the subject device and predicate device are molded to the upper arches providing a protective barrier between the individual's upper and lower teeth to prevent grinding.
It was concluded, therefore, that the technological differences do not raise different questions of safety and effectiveness.
| SUBJECT Device | Primary PREDICATE Device (K133423) | Significant Difference | |
|---|---|---|---|
| Manufacturer | DIMEDIKOREA | Ranir, LLC | - |
| Trade Name/Device name | Goyo Mouthpiece S | Rest Assured® ExtraComfort Nite Protector | - |
| Regulation Description | Mouthguard, Over-The-Counter | Mouthguard, Over-The-Counter | - |
| Product Code | OBR | OBR | No difference. |
| Class | Unclassified | Unclassified | No difference. |
| Indications for Use | The Goyo Mouthpiece Sis indicated for use as aprotection againstbruxism or nighttimeteeth grinding. Thedevice is designed toreduce tooth damageand reduce the noiseassociated with bruxismor teeth grinding. | The Rest Assured ExtraComfort Nite ProtectorDental Protector isindicated for use forprotection againstbruxism or nighttimeteeth grinding. Thedevice is intended toreduce damage to teethand to prevent the noise | No difference. |
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Image /page/6/Picture/1 description: The image shows the logo for SMB Korea. The logo has the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. There is a stylized checkmark above the SMB text.
| A Member of the Consuming Expert Group | |||
|---|---|---|---|
| SUBJECT Device | Primary PREDICATEDevice (K133423) | Significant Difference | |
|---|---|---|---|
| associated with bruxingor grinding. | |||
| OTC or Rx | OTC | OTC | No difference. |
| Materials of use | Ethylene VinylAcetateCopolymer [Elvax] | Ethylene Vinyl AcetateCopolymer [Elvax andElvaloy] | Similarities: The subjectdevice is manufacturedusing Elvax, whereas thepredicate device ismanufactured using aElvax and Elvaloy. Whilethese are not sameformulation, eachmaterial is a knowndental thermoplasticpolymer with similarcharacteristics. Bothsubject device and thepredicate are composedof flavorless, colorlessthermoplastic elastomerresins designed for dentalmouth guards and thisdifference do not affectthe safety andeffectiveness of subjectdevice. |
| Molding method | Boil and Bite Method(Heat & Bite Self-Fit) | Boil and Bite Method(Heat & Bite Self-Fit) | No difference. |
| Method ofManufacturing | Injection molding | Injection molding | No difference. |
| Location of Use | Upper Arch Teeth | Upper Arch Teeth | No difference. |
| Molding Time | 60 seconds in boilingwater; 30 seconds tomold in mouth | 60 seconds in boilingwater; 30 seconds tomold in mouth | No difference. |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Similarities: The archshape does not introduceany additional safety orefficacy concerns. |
| Dimension | W: Avg. 70.38mm;L: Avg. 47.32mm; | W: Avg. 66.6mm;L: Avg. 43.72mm; | Similarities: Although thesubject device is larger inwidth, length, and heightthan the predicatedevice, it is designed tobe thinner, making iteasier to wear, and doesnot introduce anyadditional safety or |
| SUBJECT Device | Primary PREDICATEDevice (K133423) | Significant Difference | |
| efficacy concerns.Though not identical, the width measurement of the subject device is similar to the predicate device through demonstrated through mechanical testing of the finished guard. | |||
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | No difference. |
| Tear Strength | Avg. 60.3 ± 4.13 N | Avg. 58.6 ± 4.92 N | - |
| Sterilization | Non-sterile | Non-sterile | No difference. |
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Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo consists of the letters "SMB" in a bold, sans-serif font, with the word "Korea" in a smaller, lighter font to the right. A curved line underlines the letters "SMB". Below the line, the text "A Member of the Consulting Expert Group" is written in a smaller font.
The table above shows some minor differences between the subjective device and the predicate device. But these differences do not affect the safety and effectiveness of subject device.
IX. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination:
Biocompatibility testing
The biocompatibility evaluation for the Goyo Mouthpiece S was conducted in accordance with the FDA Guidance entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", SEPTEMBER 2020, as recognized by the FDA." The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization
- Irritation
Mechanical testing
Mechanical tests were performed to determine the appearance, dimensions, Shore A hardness, tensile strength, tear strength, water sorption, and water solubility of the mouthguard.
X. CLINICAL PERFORMANCE DATA
Clinical performance data demonstrating substantial equivalence have not been provided.
XI. CONCLUSIONS
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Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A stylized swoosh underlines the "SMB" portion of the logo.
The Goyo Mouthpiece S has been compared to predicate devices for safety and effectiveness. The information provided in this premarket notification demonstrates that the subject device has been determined to be substantially equivalent (SE) to the predicate devices.
N/A