(266 days)
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism – the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.
It appears there might be a misunderstanding of the provided document. The document is an FDA 510(k) clearance letter for a dental guard (CustMBite Dental Guard) and its associated 510(k) summary. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device, as required for 510(k) clearance.
This document does not describe an AI/ML-driven medical device, nor does it contain information about acceptance criteria for an AI model's performance, a study proving an AI device meets acceptance criteria, expert adjudication, or MRMC studies.
Instead, it details:
- Device: CustMBite Dental Guard, an over-the-counter dental guard for bruxism.
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
- Key Information for a Traditional Device:
- Indications for Use (protection against bruxism, reduction of damage/noise from teeth grinding, for individuals 18+)
- Device Description (boil-and-bite, self-fit mouthguard)
- Predicate Device (Oral-B plus Scope Outlast Nighttime Dental Guard, K113326)
- Comparison of Technological Characteristics (similarities in product code, classification, indications, intended use, anatomical site, molding, fit, reusability, biocompatibility, cleaning, labeling; primary difference being the absence of flavor in the new device)
- Non-Clinical Testing (biocompatibility testing according to ISO standards)
- Clinical Testing: "No clinical study was conducted."
Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML device, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, because this document is not about an AI/ML-driven device. It is about a traditional, physical dental device.
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August 23, 2019
Dental Choice Holdings, LLC % E.J. Smith, Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114
Re: K183315
Trade/Device Name: CustMBite Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: July 24, 2019 Received: July 25, 2019
Dear E.J. Smith:
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/cfpmp/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events)
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(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-safetyreporting-combination-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-devices/medical-device-safety/medical-devicereporting-mdr-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.
for 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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Indications for Use
510(k) Number (if known) K183315
Device Name CustMBite Dental Guard
Indications for Use (Describe)
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
| 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
| Submitter: | Dental Choice Holdings, LLC |
|---|---|
| Address: | 10100 Linn Station RoadLouisville, KY 40223 |
| Contact Person: | Ron StoryVice President and Chief Information Officer |
| Telephone Number: | 502-736-4600 |
| Email: | Ron.Story@deltadentalky.com |
Summary Preparation Date: August 21, 2019
| Device Description | |
|---|---|
| Trade Name: | CustMbite Dental Guard |
| Common Name: | Mouthguard, over-the-counter |
| Regulatory Class: | |
| Product Code: | OBR |
| C.F.R. Section: | Unclassified |
Predicate Device:
| Brand Name | 510(k) Number |
|---|---|
| Oral-B plus Scope Outlast Nighttime Dental Guard | K113326 |
Device Description
CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.
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Indications for Use
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism – the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
| Parameters | Dental ChoiceHoldings, LLCCustMBite DentalGuard | Predicate DeviceOral-B plus ScopeOutlast NighttimeDental Guard | Similarities andDifferences |
|---|---|---|---|
| Product Code | OBR | OBR | Similar |
| Product Classification | Unclassified | Unclassified | Similar |
| Classification Name | Mouthguard, OTC | Mouthguard, OTC | Similar |
| Indications for Use | The CustMBite DentalGuard is an over-the-counter dental guardindicated for theprotection againstbruxism - thenighttime clenchingand grinding of theteeth.It is intended for use inthe mouth at night toreduce damage to theteeth and to preventthe noise associatedwith teeth grinding.The CustMBite DentalGuard is intended forindividuals age 18 andolder. | The Oral B plus ScopeOutlast NighttimeDental Guard is anover-the-counterdental guard indicatedfor the protectionagainst bruxism - thenighttime clenchingand grinding of theteeth.It is intended for use inthe mouth at night toreduce damage to theteeth and to preventthe noise associatedteeth grinding. | Similar |
| Intended Use | Aids in the reductionof tooth damage andnoise due to bruxingand grinding | Aids in the reductionof tooth damage andnoise due to bruxingand grinding | Similar |
| Anatomical Site andType of Use | Intraoral, duringsleep | Intraoral, duringsleep | Similar |
| Parameters | Dental ChoiceHoldings, LLCCustMBite DentalGuard | Predicate DeviceOral-B plus ScopeOutlast NighttimeDental Guard | Similarities andDifferences |
| Materials | Propylene-basedelastomer | Propylene-basedelastomer and flavor | CustMBite does notcontain a flavor |
| Molding Method | Heat & Bite Self-fit | Heat & Bite Self-fit | Similar |
| Fit | One size fits all viatraditional heatand bite | One size fits all viatraditional heatand bite | Similar |
| Reusable | YesSingle Patient | YesSingle Patient | Similar |
| Biocompatibility | Biocompatibilitytesting conducted inaccordance ISO10993-1 | Biocompatibilitytesting conducted inaccordance ISO10993-1 | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Compatibility withthe Environment &Other Devices | Label warningsagainst use withcertain other dentalaccessories | Label warningsagainst use withcertain other dentalaccessories | Similar |
| Cleaning | Scrub withtoothbrush,toothpaste and coldwater | Scrub withtoothbrush,toothpaste and coldwater | Similar |
Substantial Equivalence Discussion
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Discussion of Technological Differences
-
a. Similarities:
The CustMbite Dental Guard has the following similarities to the predicate device: indications for use, intended use, anatomical site, material, molding method, customized fit., reusable, non-sterile, biocompatibility, cleaning and label warning. -
b. Differences:
The predicate device offers flavors for the dental guard and the CustMbite Dental Guard offers no flavors.
Non-Clinical Testing
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- ISO 14971 Second edition 2007-03-01 Medical devices Application of risk . management to medical devices
- . ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI/ISO 10993-3:2014. Biological Evaluation of Medical Devices--Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ANSI/AAMI/ISO 10993-12: 2012. Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
- ISO 10993-10, 2010, Biological Evaluation of Medical Devices - Part 10: Tests for
- Irritation and Skin Sensitization ●
- ISO/IEC 17025, 2017, General Requirements for the Competence of Testing and
- Calibration Laboratories
- ISO 10993-11, 2017, Biological Evaluation of Medical Devices Part 11: Tests for . Systemic Toxicity
Clinical Testing
No clinical study was conducted.
Conclusion
Based upon similarities in indications for use, materials and principle of operation together with performance testing, we find that CustMbite Dental Guard to be substantially equivalent to Oral B plus Scope Outlast Nighttime Dental Guard (K113326).
N/A