(89 days)
No
The summary describes a physical mouth guard and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is indicated for "protection of teeth and restorations against grinding and clenching" and "preventing tooth damage caused by bruxism," which are therapeutic aims to mitigate a condition.
No
Explanation: The device description states its purpose is to create a physical separation between teeth to prevent damage from grinding and clenching. It does not mention any function for identifying, analyzing, or diagnosing any medical condition. Its function is purely protective/therapeutic.
No
The device description clearly states it is a "mouth guard used as a barrier between teeth," indicating a physical, hardware device. The performance studies also focus on durability, dimensional accuracy of manufacturing, and biocompatibility, which are all related to a physical product.
Based on the provided information, the Remi Night Guard is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical protection of teeth against grinding and clenching. This is a mechanical function, not a diagnostic one.
- Device Description: The description clearly states it's a mouth guard used as a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on durability, dimensional accuracy, and biocompatibility – all related to the physical properties and safety of the device for its intended mechanical use. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Remi Night Guard does not fit this description.
N/A
Intended Use / Indications for Use
The Remi Custom Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
Product codes (comma separated list FDA assigned to the subject device)
MQC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Worn on maxillary or mandibular teeth
Indicated Patient Age Range
Not Found
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LIJIA Night Guard (K241369)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Thermoforming Sheet Materials (K200125)
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). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 (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
2
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
3
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)
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
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 6792 |
| Houston, 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.
5
Comparison to Predicate Devices:
Table 1. Predicate Comparison
| Specification | Subject Device:
Remi Custom Night Guard | Predicate Device:
LIJIA Night Guard | Comparison
Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------|
| Product Code | MQC | MQC | Same |
| Classification
Panel | Dental | Dental | Same |
| Device Class | Unclassified | Unclassified | Same |
| OTC or Rx | Rx | Rx | Same |
| Anatomical
Sites | Worn on maxillary or mandibular
teeth | Worn on maxillary or
mandibular teeth | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Patient
Removable? | Yes | Yes | Same |
| Indication for
Use | The Remi Custom Night Guard is
indicated for protection of teeth
and restorations against grinding
and clenching. | The LIJIA Night Guard is
indicated for protection of
teeth and restorations against
grinding 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.
6
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.