(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a moldable dental guard, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device description and intended use clearly state that the LunaGuard™ helps protect teeth and reduce damage caused by bruxism or nighttime grinding. This function directly aims to alleviate or prevent a medical condition (bruxism) and its associated damage, thus classifying it as a therapeutic device.
No
Explanation: The device is described as a "Nighttime Dental Protector" indicated for protecting teeth and reducing damage caused by bruxism or grinding. Its function is to absorb forces and act as a barrier, not to diagnose a condition.
No
The device description explicitly states it is a physical dental guard made of PCL plastic material, which is a hardware component. There is no mention of any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- LunaGuard™ Function: The LunaGuard™ Nighttime Dental Protector is a physical device that is placed in the mouth to protect teeth from grinding. It does not analyze any biological specimens or provide diagnostic information about a person's health. Its function is purely mechanical protection.
- Intended Use: The intended use clearly states it's for "protecting the teeth and reducing damage caused by bruxism or nighttime grinding." This is a protective and preventative function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the material and how it works mechanically to absorb forces and create a barrier. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the LunaGuard™ Nighttime Dental Protector falls under the category of a dental device for protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.
When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing.
The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral (i.e., mucosal, gingival, and palatal) surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user / Over-The-Counter
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: Biocompatibility testing on patient contacting materials was completed in accordance with the requirements of ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The LunaGuard™ is categorized as a surface device that contacts intraoral (i.e., mucosal, gingival, and palatal) surfaces for limited contact. Results show that the device is biocompatible for its intended use.
Non-Clinical Testing: The physical properties of the LunaGuard™ device were tested against those of the predicate. Comparative testing found the devices to be equivalent with respect to density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
August 5, 2019
McKeon Products % Elizabeth FitzGerald Director, Regulatory Intelligence Right Submission LLC 59 High Street Newton, Massachusetts 02464
Re: K191033
Trade/Device Name: LunaGuard Nighttime Dental Protector Regulatory Class: Unclassified Product Code: OBR Dated: May 7, 2019 Received: May 8, 2019
Dear Elizabeth FitzGerald:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191033
Device Name
LunaGuard™ Nighttime Dental Protector
Indications for Use (Describe)
The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
| 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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3
K191033
5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Devin Benner |
|---|---|
| CEO | |
| McKeon Products | |
| 25460 Guenther | |
| Warren, MI 48091 USA | |
| Telephone: 586-427-7560 | |
| devin@macksearplugs.com | |
| Contact: | Elizabeth FitzGerald |
| Director, Regulatory Intelligence | |
| Right Submission LLC | |
| 59 High Street | |
| Newton, MA 02464 USA | |
| Telephone: 781-413-7345 | |
| elizabeth@rightsubmission.com | |
| Date Summary Prepared: | April 17, 2019 |
5.2 Name of the Device
| Trade Name: | LunaGuard™ Nighttime Dental Protector |
|---|---|
| Common Name: | Over-the-Counter Dental Guard |
| Classification Name: | Mouthguard, Over-the Counter |
| Review Panel: | Dental |
| Regulation: | Unclassified |
| Class: | Class II |
| Product Code: | OBR |
5.3 Equivalence Claimed to Predicate Device
The LunaGuard™ Nighttime Dental Protector is equivalent to the Pro Tech Dent (K121272), manufactured by Akervall Technologies Inc..
5.4 Device Description
The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and
4
absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.
When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing.
The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.
5.5 Indications for Use
The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
The Indications for Use of the subject device is identical to the Indications for Use of the predicate device, the ProTech Dent.
5.6 Comparison of Technological Characteristics
The LunaGuard™ and the ProTech Dent have the same intended use and indications for use, and are similar in terms of design, materials, method of action, and principles of operation. They are over-the-counter re-moldable dental guards, provided non-sterile for a single user. They are composed of the same polycaprolactone (PCL) plastic material, are the same thickness (1.6 mm), and were found to have similar physical properties as demonstrated by comparative performance testing. Both were found to be biocompatible per ISO 10993.
5.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing
Biocompatibility testing on patient contacting materials was completed in accordance with the requirements of ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The LunaGuard™ is categorized as a surface device that contacts intraoral (i.e., mucosal, gingival, and palatal) surfaces for limited contact. Results show that the device is biocompatible for its intended use.
Non-Clinical Testing
The physical properties of the LunaGuard™ device were tested against those of the predicate. Comparative testing found the devices to be equivalent with respect to density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing.
5.8 Conclusion
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Performance testing and comparison of technological characteristics between the LunaGuard™ and the predicate demonstrate that the LunaGuard™ is substantially equivalent with regard to intended use, operation, function, and technological characteristics.