(89 days)
The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
This document is a 510(k) Premarket Notification from the FDA regarding a dental device called the "Remi Custom Night Guard." It states that the device is substantially equivalent to a legally marketed predicate device (LIJIA Night Guard), meaning a full clinical study with acceptance criteria and a detailed study report is not required.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
The document explicitly states:
- "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." (page 6)
Instead, the submission relies on:
- Comparison to a Predicate Device: The Remi Custom Night Guard is shown to have the same indications for use, product code, classification, anatomical sites, sterility, patient removability, and general technological features as the predicate LIJIA Night Guard (K241369).
- Non-Clinical Performance Testing:
- Durability testing: Completed, but no details on specific acceptance criteria or results are provided.
- Internal manufacturing validation: Performed to test the dimensional accuracy of the manufacturing process, but no specific acceptance criteria or results are provided.
- Biocompatibility testing: Performed in accordance with ISO 10993, with cytotoxicity testing completed. No specific acceptance criteria or results are provided beyond the statement that it was completed.
In summary, because this is a 510(k) submission based on substantial equivalence to a predicate device and explicitly states that no clinical studies were deemed necessary, the detailed information about acceptance criteria and a study to prove device performance (as requested in the prompt) is not present in this document.
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February 10, 2025
GrindGuard Inc % Jennifer Day Regulatory Correspondent Prime Path Medtech 1321 Upland Dr Suite 6792 Houston, Texas 77043
Re: K243516
Trade/Device Name: Remi Custom Night Guard Regulatory Class: Unclassified Product Code: MQC Dated: November 13, 2024 Received: November 13, 2024
Dear Jennifer Day:
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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assistance/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).
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Remi Custom Night Guard
Indications for Use (Describe)
The Remi Night Guard is indicated for protection of teeth and restorations 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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510(k) Summary
K243516
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | GrindGuard Inc |
|---|---|
| Company Contact Person: | Oscar Adelman |
| Address: | 155 Jackson St, 1206, San Francisco CA 94111 |
| Phone: | 917-634-1180 |
| Email: | oscar@shopremi.com |
| Submission Correspondent: | Jennifer Day, Regulatory Affairs Consultant |
| Address: | 1321 Upland Dr. Suite 6792Houston, TX 77043 |
| Phone: | 314-809-1919 |
| Email: | jday@primepathmedtech.com |
| Date Prepared: | 1/27/25 |
| Proprietary Name: | Remi Custom Night Guard |
| 510(k) Number | K243516 |
| Common Name: | Mouth Guard |
| Product Code: | MQC |
| Device Classification: | Unclassified |
| Predicate Device: | LIJIA Night Guard (K241369) (Primary Predicate) |
| Reference Device: | Thermoforming Sheet Materials (K200125) |
Device Description:
The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
Indications for Use:
The Remi Custom Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
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Comparison to Predicate Devices:
Table 1. Predicate Comparison
| Specification | Subject Device:Remi Custom Night Guard | Predicate Device:LIJIA Night Guard | ComparisonResult |
|---|---|---|---|
| Product Code | MQC | MQC | Same |
| ClassificationPanel | Dental | Dental | Same |
| Device Class | Unclassified | Unclassified | Same |
| OTC or Rx | Rx | Rx | Same |
| AnatomicalSites | Worn on maxillary or mandibularteeth | Worn on maxillary ormandibular teeth | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| PatientRemovable? | Yes | Yes | Same |
| Indication forUse | The Remi Custom Night Guard isindicated for protection of teethand restorations against grindingand clenching. | The LIJIA Night Guard isindicated for protection ofteeth and restorations againstgrinding and clenching. | Same |
Indications for Use:
The indication for use is the same as the predicate device, the LIJIA Night Guard. Both of the devices are indicated for the protection of teeth against grinding and clenching.
Technological Features:
The Remi Custom Night Guard uses the same mechanism of action as the predicate product and reference product. It is intended to be worn on the teeth to protect teeth against grinding and clenching and to mitigate the pains associated with temporomandibular disorders.
Non-Clinical Performance Testing
The use of thermoplastic materials for Night Guards has been well documented in scientific literature. However, durability testing was completed on these night guards.
An internal manufacturing validation was performed to test the dimensional accuracy of the manufacturing process for the Night Guards.
Biocompatibility testing was performed on the subject device in accordance with ISO 10993. Cytotoxicity testing was completed.
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Clinical Performance Testing
The technological characteristics, indications for use, material, and manufacturing and processes are the same or similar to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Conclusion
Based on the similarities in indications for use, technological characteristics, and non-clinical performance testing the Night Guards are substantially equivalent to the predicate device.
N/A