(264 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and biocompatibility of a simple, moldable mouthguard. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for use as a protection against bruxism or nighttime teeth grinding, and is designed to reduce tooth damage and noise associated with these conditions, which are therapeutic goals.
No
The device is a mouthguard intended to protect against bruxism by acting as a physical barrier. It does not provide any diagnostic information or perform any diagnostic functions.
No
The device description clearly states it is a physical mouthguard made of ethylene vinyl acetate (EVA), which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Goyo Mouthpiece S Function: The Goyo Mouthpiece S is a physical device worn in the mouth to protect teeth from grinding. It does not analyze any biological specimens or provide diagnostic information.
- Intended Use: The intended use clearly states it's for "protection against bruxism or nighttime teeth grinding" and to "reduce tooth damage and reduce the noise associated with bruxism or teeth grinding." This is a mechanical protective function, not a diagnostic one.
- Device Description: The description details a physical, moldable mouthguard made of EVA. There is no mention of any components or processes related to analyzing biological samples.
Therefore, based on the provided information, the Goyo Mouthpiece S is a medical device, but it falls under a different category than In Vitro Diagnostics. It is likely classified as a Class II dental device.
N/A
Intended Use / Indications 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.
Product codes
OBR
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arch Teeth
Indicated Patient Age Range
eighteen (18) years of age or older
Intended User / Care Setting
Over-The-Counter Use
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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
3
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® Extra | |
| Comfort 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 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 Rest Assured Extra | ||
| Comfort Nite Protector | |||
| Dental Protector is | |||
| indicated for use for | |||
| protection against | |||
| bruxism or nighttime | |||
| teeth grinding. The | |||
| device is intended to | |||
| reduce damage to teeth | |||
| and 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 PREDICATE
Device (K133423) | Significant Difference |
|----------------------------|----------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | associated with bruxing
or grinding. | |
| OTC or Rx | OTC | OTC | No difference. |
| Materials of use | Ethylene Vinyl
Acetate
Copolymer [Elvax] | Ethylene Vinyl Acetate
Copolymer [Elvax and
Elvaloy] | Similarities: The subject
device is manufactured
using Elvax, whereas the
predicate device is
manufactured using a
Elvax and Elvaloy. While
these are not same
formulation, each
material is a known
dental thermoplastic
polymer with similar
characteristics. Both
subject device and the
predicate are composed
of flavorless, colorless
thermoplastic elastomer
resins designed for dental
mouth guards and this
difference do not affect
the safety and
effectiveness of subject
device. |
| Molding method | Boil and Bite Method
(Heat & Bite Self-Fit) | Boil and Bite Method
(Heat & Bite Self-Fit) | No difference. |
| Method of
Manufacturing | Injection molding | Injection molding | No difference. |
| Location of Use | Upper Arch Teeth | Upper Arch Teeth | No difference. |
| Molding Time | 60 seconds in boiling
water; 30 seconds to
mold in mouth | 60 seconds in boiling
water; 30 seconds to
mold in mouth | No difference. |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Similarities: The arch
shape does not introduce
any additional safety or
efficacy concerns. |
| Dimension | W: Avg. 70.38mm;
L: Avg. 47.32mm; | W: Avg. 66.6mm;
L: Avg. 43.72mm; | Similarities: Although the
subject device is larger in
width, length, and height
than the predicate
device, it is designed to
be thinner, making it
easier to wear, and does
not introduce any
additional safety or |
| | SUBJECT Device | Primary PREDICATE
Device (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.