(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a simple, moldable mouth guard. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
Explanation: The device is intended to protect against grinding and clenching, which addresses a medical condition (bruxism) and provides therapeutic benefits by preventing tooth wear and associated symptoms.
No
The device description indicates it is a mouth guard intended to protect against grinding and clenching, acting as a barrier. The performance studies focus on material properties and physical performance rather than diagnostic capabilities. There is no mention of the device analyzing or providing information about a patient's condition for diagnosis.
No
The device description explicitly states it is a physical mouth guard made of thermoplastic material, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect against grinding and clenching by acting as a physical barrier in the mouth. This is a mechanical function, not a diagnostic one.
- Device Description: The description details a physical mouth guard made of thermoplastic material. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Activity: There is no mention of the device being used to detect, measure, or analyze any substances or markers within the body or in biological samples.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the mouth guard (hardness, water absorption, wear, toxicity, etc.). These are relevant to a physical device worn in the mouth, not to a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This mouth guard does not fit that description.
N/A
Intended Use / Indications for Use
The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.
Product codes
OBR
Device Description
The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Adults 18 and older
Intended User / Care Setting
Not Found
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)
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.
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
Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
Indications for Use
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: xmyizhou@hotmail.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
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
5
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 | ||
| Mouth molding time: 20-25 seconds | In hot water time: 15-20 seconds | ||
| Mouth molding time: | |||
| 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 | |||
| more than twelve (12) hours per | |||
| day. | Worn during sleeping for no | ||
| more than twelve (12) hours | |||
| per day. | |||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Anatomical site of | |||
| use | Oral cavity | Oral cavity | Same |
| Biocompatibility | ISO 10993 complies | ISO 10993 complies | Same |
F. Comparison with predicate device
2
6
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.