Anti Grinding Guard

K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · OBR · May 24, 2024 · DE

Device Facts

• Record ID: K240810
• Device Name: Anti Grinding Guard
• Applicant: Xiamen Yizhou Imp. & Exp. Co., Ltd.
• Product Code: OBR · DE
• Decision Date: May 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching. Keep upper and lower teeth separated during sleep.

Device Story

Anti Grinding Guard is an over-the-counter, flexible, moldable, one-piece dental mouth guard; intended for use by adults 18+ to protect against grinding and clenching during sleep. Device functions as a physical barrier between upper and lower teeth. User performs 'boil and bite' self-fitting process by heating the thermoplastic ethylene-vinyl acetate copolymer guard in hot water (15-20 seconds) and molding to teeth (20-25 seconds). Device is non-sterile, reusable by a single individual, and replaced every four months. Provides benefit by preventing dental damage associated with bruxism.

Clinical Evidence

No clinical data. Bench testing only, including hardness, water absorption, solubility, boiling/cooling water testing, impression testing, separation testing, and comparative wear testing. Biocompatibility testing included cytotoxicity, oral mucosa irritation, skin sensitization, acute/sub-chronic systemic toxicity, and genotoxicity.

Technological Characteristics

Material: 100% thermoplastic ethylene-vinyl acetate copolymer. Form factor: Flexible, moldable one-piece dental guard. Manufacturing: Injection molding. Biocompatibility: ISO 10993 compliant. Sterility: Non-sterile. Operation: Boil-and-bite self-fit.

Indications for Use

Indicated for adults 18 years and older for protection against teeth grinding and clenching during sleep.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

• Bright Guard (K181099)

Submission Summary (Full Text)

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May 24, 2024

Xiamen Yizhou Imp. & Exp. Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 CHINA

Re: K240810 Trade/Device Name: Anti Grinding Guard Regulatory Class: Unclassified Product Code: OBR Dated: March 25, 2024 Received: March 25, 2024

Dear Ivy Wang:

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.

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"

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(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 OS 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 ([e-mail]) or phone [phone] 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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# Indications for Use

Submission Number (if known)

K240810

Device Name

### Anti Grinding Guard

Indications for Use (Describe)

The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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# K240810 510(K) Summary

Prepared date: 2024-03-18 A. Applicant: Xiamen Yizhou Imp. & Exp. Co., Ltd. Address: 2F, 1#, Huli Industrial Park, Meixi Road, Tong An District, Xiamen City, Fujian, China Contact Person: Elaine Huang Tel: + 86 13859990367 Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### B. Device:

Trade Name: Anti Grinding Guard Common Name: Over-the-Counter Dental Guard Model: YZ9003

Regulatory Information Classification Name: Mouthguard, Over-the Counter Regulation Number: N/A Product Code: OBR Unclassified Device Class: Review Panel: Dental

#### C. Predicate device:

510(k) Number: K181099 Trade Name: Bright Guard Manufacturer: Koncept Innovators, LLC.

#### D. Indications for use of the device:

The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.

#### E. Device Description:

The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental

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mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

| Table 1 General Comparison | | | |
|-------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------|
| Device | Proposed Device | Predicate Device | Result |
| 510K number | - | K181099 | - |
| Model name | Anti Grinding Guard | Bright Guard | - |
| Classification | Unclassified | Unclassified | Same |
| Regulation | N/A | N/A | Same |
| Product code | OBR | OBR | Same |
| Indications for use | The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching. | Bright Guard is a mouth guard intended to protect against grinding and clenching. | Same |
| Intended use | Keep upper and lower teeth separated during sleep. | Keep upper and lower teeth separated during sleep. | Same |
| OTC use | Yes | Yes | Same |
| Target population | Adults 18 and older | Adults 18 and older | Same |
| Technological characteristics | Flexible, moldable guard used as a barrier between teeth. | Flexible, moldable guard used as a barrier between teeth. | Same |
| Molding Method | Boil and Bite Method (Heat & Bite Self-Fit) | Boil and Bite Method (Heat & Bite Self-Fit) | Same |
| Material | Ethylene-vinyl acetate copolymer | Ethylene-vinyl acetate copolymer | Same |
| Location of Use | Upper Arch Teeth | Upper Arch Teeth | Same |
| Method of manufacture | Injection molding | Injection molding | Same |
| Molding time | In hot water time: 15-20 seconds<br>Mouth molding time: 20-25 seconds | In hot water time: 15-20 seconds<br>Mouth molding time:<br>20-25 seconds | Same |
| Wear Time | Four (4) months wear time until replacement with new mouth guard | Four (4) months wear time until replacement with new mouth guard | Same |
| | Worn during sleeping for no<br>more than twelve (12) hours per<br>day. | Worn during sleeping for no<br>more than twelve (12) hours<br>per day. | |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Anatomical site of<br>use | Oral cavity | Oral cavity | Same |
| Biocompatibility | ISO 10993 complies | ISO 10993 complies | Same |

# F. Comparison with predicate device

2

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# G. Non-Clinical Test Conclusion

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the proposed device including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, and comparative wear test to demonstrate its effectiveness.

The non-clinical testing of Anti Grinding Guard demonstrates the device's performance in providing including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, separation test, and comparative wear test, which supports its substantial equivalence to the predicate device.

Additionally, the following tests for biocompatibility were conducted on the Mouth Guard.

- Cytotoxicity
- Oral Mucosa Irritation ●
- Skin Sensitization
- Acute systemic toxicity
- Sub chronic systemic toxicity
- Genotoxicity

The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate.

## H. Clinical Test Conclusion

No clinical study is included in this submission.

#### I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K181099.