Bright Guard is comprised of a mouth guard, spatula and storage case. The mouth guard is an over-the-counter, flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individuals who grind their teeth. Bright Guard mouth guard is intended to be worn while sleeping. The mouth guard material is conformable to wear, and it can be self-fit by the 'boil and bite' method (submerging in hot water to make the material malleable to fit on the upper teeth of the oral cavity). Bright Guard mouth guard is constructed of 100% Thermoplastic resin Propylene Elastomer (TPE) material (ethylene-vinyl-acetate) [Elvax]. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. Bright Guard does not contain Bisphenol A (BPA) or phthalates and is free of natural rubber latex. The spatula and storage case are composed of 100% Polypropylene. The materials in Bright Guard are used in various other 510(k) cleared dental mouth guards. The three components (mouth guard, spatula and storage case) are manufactured by injection molding. Bright Guard mouth guard Is provided in one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Bright Guard," a mouth guard intended to protect against grinding and clenching. It outlines the device's characteristics, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

However, the provided document does not describe acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity, or human performance improvement with AI assistance).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on material composition, functional design, intended use, and non-clinical performance tests (biocompatibility and functional tests). There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain such information for an AI/ML device.

The document explicitly states:

"There were no clinical tests performed or provided in this submission." This means no human subject studies were conducted to assess clinical efficacy or performance.
The performance data provided relates to "functional non-clinical performance tests" (Hardness, Water Sorption and Solubility, Spatula & Mouth guard Boiling/Cooling Water Testing) and "biocompatibility assessment" (Cytotoxicity, Skin Sensitization, Oral Mucosal Irritation). These are material and safety tests, not performance metrics like accuracy, sensitivity, or human-AI reader improvement.

Based on the provided information, the device is a simple "boil and bite" mouth guard, not an AI-powered device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable to this submission.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

Koncept Innovators, LLC. % Maureen Garner President New World Regulatory Solutions. Inc. 11700 W. Charleston Boulevard Suite 170-390 Las Vegas, Nevada 89135

Re: K181099

Trade/Device Name: Bright Guard Regulatory Class: Unclassified Product Code: OBR Dated: December 19, 2018 Received: December 21, 2018

Dear Maureen Garner:

We have reviewed vour 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 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

January 18, 2019

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S.
Digitally signed by
Mary S. Runner -S3
Runner -S3 Date: 2019.01.18
08:12:19-05'00'

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

-73

510(k) Number (if known) K181099

Device Name Bright Guard

Indications for Use (Describe)

Bright 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)

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510(k) Summary for Bright Guard

K181099

Date of 510(k) Summary Preparation: January 15, 2019

1. Trade (Proprietary) Name: Bright Guard
1. Common Name: Mouth Guard, Over-The-Counter

3. Contact Information

Primary [Regulatory Correspondent]

Contact:	Maureen Garner, PresidentNew World Regulatory Solutions, Inc.
Email:	NWRSinc@gmail.com
Phone:	732-779-7422
Fax:	702-527-7836
Address:	New World Regulatory Solutions, Inc.11700 W. Charleston BlvdSuite 170 – 390Las Vegas, NV 89135

Secondary [Applicant/Sponsor]

Contact:	Sylvan Newby, PresidentKoncept Innovators, LLC.
Email:	sylvan@glidegear.com
Phone:	843-945-4031
Address:	Koncept Innovators, LLC.1619 Executive AvenueMyrtle Beach, SC 29577 USA

4. Device Classification & Panel

Classification Panel:	Dental
Classification Name:	Unclassified, Pre-Amendment
Product Code:	OBR
Trade/Proprietary Name:	Bright Guard
Common Name:	Mouth Guard

5. Primary Predicate Device: GrindGuardN, K133037; Reference Device: Rest Assured Extra Comfort Nite Protector Dental Protector, K133423.

6. Device Description

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resin Propylene Elastomer (TPE) material (ethylene-vinyl-acetate) [Elvax]. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. Bright Guard does not contain Bisphenol A (BPA) or phthalates and is free of natural rubber latex. The spatula and storage case are composed of 100% Polypropylene. The materials in Bright Guard are used in various other 510(k) cleared dental mouth guards. The three components (mouth guard, spatula and storage case) are manufactured by injection molding. Bright Guard mouth guard Is provided in one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

7. Indications for Use

Bright Guard is a mouth guard intended to protect against grinding and clenching. For over-thecounter use.

8. Summary of Substantial Equivalence

Bright Guard, like the primary predicate (GrindGuardN, K133037) and reference device (Rest Assured Extra Comfort Nite Protector Dental Protector), cushions the teeth and keeps the upper teeth from contacting the bottom teeth. In this way, Bright Guard, like the predicate and reference device, acts as a protective barrier between teeth.

Bright Guard has the same technical characteristics as the predicate and reference devices, a soft, formable propylene-based elastomer/thermoplastic resin that, by way of the 'boil and bite' method, is fitted to an individual. Both the Bright Guard and predicate device are molded to the upper arches providing a protective barrier between the individual's upper and lower teeth to prevent grinding.

Bright Guard and the predicate device have the same intended use, indications for use and principle of operation.

The table below compares the technological characteristics of Bright Guard and the primary predicate and reference device.

	Subject Device	Primary Predicate Device	Reference Device	Similarities and Differences
Trade Name /Brand Name	Bright Guard	GrindGuardN	Rest Assured ExtraComfort Nite ProtectorDental Protector	N/A
510(k)#	K181099	K133037	K133423	N/A
Indications forUse	Bright Guard is amouth guardintended toprotect againstgrinding andclenching.	GrindGuardN is amouth guard intendedto protect againstgrinding andclenching.	The Rest Assured ExtraComfort Nite ProtectorDental Protector isindicated for use forprotection againstbruxism or night timeteeth grinding. Thedevice is intended toreduce damage to teethand to prevent the noiseassociated with bruxingor grinding.	Both Bright Guardand the predicateprovide a barrierbetween the upperand lower teeth toprevent bruxism.
DeviceDescription	Flexible,moldable mouthguard used as abarrier between	Flexible, moldablemouth guard used asa barrier between	Flexible, moldablemouth guard used as abarrier between teeth fornighttime teeth grinding	Both Bright Guardand the predicate usemoldable "boil and
	Subject Device	Primary PredicateDevice	Reference Device	Similarities andDifferences
	teeth fornighttime teethgrinding.	teeth for nighttimeteeth grinding.		"bite" technology toprovide a custom fit.
Molding Method	Boil and BiteMethod (Heat &Bite Self-Fit)	Boil and Bite Method(Heat & Bite Self-Fit)	Boil and Bite Method(Heat & Bite Self-Fit)	Both Bright Guardand the predicate usemoldable "boil andbite" technology toprovide a custom fit.
Rx or OTC	OTC	OTC	OTC	Both Bright Guardand the predicatedevice are indicatedfor over-the-counteruse.
Method ofManufacturing	InjectionMolding	Injection Molding	Injection Molding	Both Bright Guardand the predicate aremanufactured byinjection molding.
Biocompatibility	BiocompatibleMaterials Used	BiocompatibleMaterials Used	Biocompatible MaterialsUsed	Both Bright Guardand the predicate usebiocompatiblematerials testedaccording to ISO10993.
Sterility	Non-Sterile	Non-Sterile	Non-sterile	Both Bright Guardand the predicate aresupplied non-sterile.
Contact Material	Thermoplasticresin PropyleneElastomer:ethylene-vinyl-acetate [Elvax]No Flavor; NoColor Additives	Thermoplastic resinPropylene Elastomer:polycalprolactoneNo Flavor; No ColorAdditives	Thermoplastic resinPropylene Elastomer:ethylene-vinyl-acetate[Elvax and Elvaloy]No Flavor; No ColorAdditives	Both Bright Guardand the predicate arecomposed offlavorless, colorlessthermoplasticelastomer resinsdesigned for dentalmouth guards
Location of Use	Upper ArchTeeth	Upper Arch Teeth	Upper Arch Teeth	Both Bright Guardand the predicate areplaced on the upperarch teeth.
Wear Time	Four (4) monthswear time untilreplacement withnew mouth guardWorn duringsleeping for nomore than twelve(12) hours perday.	Six (6) -eight (8)months wear timeuntil replacementwith new mouthguardNot stated on IFU	For more than thee (3)months for initial usewithout consultingdentist. See dentist every6 months thereafterwhile using this product.Not stated in IFU	Bright Guard is wornfor 4 months whilethe predicate can beworn over a 6 to 8month period.
Molding Time	In hot watertime: 15-20seconds; Mouthmolding time:20-25 seconds	In hot water time: 10seconds; Mouthmolding time: 20seconds	60 seconds in boilingwater; 30 seconds tomold in mouth	The predicate has a10 second shorterboil time and thesame bite time tocomplete molding.

Comparison of Characteristics

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The table above identifies a few minor differences between the subject device and the cited predicate and reference devices. The wear time and molding time are similar to the subject device. The contact material for the subject and reference devices is ethylene-vinyl-acetate;

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polycaprolactone for the primary predicate. Though not identical, the contact materials for all three devices cited are moldable thermoplastic elastomer resins that are used in other 510(k)cleared dental mouth guards that share the same intended use as the subject device.

In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent when it has the same intended use and same or similar technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any difference between the subject device and the cited predicate and reference devices are minor and do not raise questions of safety and effectiveness. It is on this basis that Bright Guard is substantially equivalent to the cited predicate device.

9. Summary of Performance Data

There were no clinical tests performed or provided in this submission.

The following functional non-clinical performance tests were conducted on Bright Guard:

Hardness, Water Sorption and Solubility Testing; and
Spatula & Mouth guard Boiling/Cooling Water Testing

A biocompatibility assessment was conducted using Bright Guard mouth guard as a final finished device in accordance with International Standard ISO 10993:2009 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process and FDA's Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016.

The following biocompatibility performance tests were conducted on Bright Guard:

In Vitro Cytotoxicity Test using ISO 10993-5:2009 Test Method - MTT Method MEM with 10%FBS extract
Skin Sensitization Test using ISO 10993-10:2010 Test Method Guinea Pig ● Maximization Test 0.9% Sodium Chloride Injection Extract
Skin Sensitization Test using ISO 10993-10:2010 Test Method - Guinea Pig Maximization Test Sesame Oil Extract
Oral Mucosal Irritation Test using ISO 10993-10:2010 Test Method - Hamster 0.9% Sodium Chloride Extract
Oral Mucosal Irritation Test using ISO 10993-10:2010 Test Method Hamster ● Sesame Oil Extract

Bright Guard relied on biocompatibility and functional performance testing as the basis for nonclinical data. The non-clinical testing performed demonstrated that the Bright Guard mouth guard is substantially equivalent to the predicate device.

Regulation Number and Section

N/A