Who is the manufacturer of Bright Guard?

Koncept Innovators, LLC filed the 510(k) submission for Bright Guard (K181099).

What is the FDA product code for Bright Guard?

OBR. as a Class U device in the DE panel.

What is the regulatory pathway for Bright Guard?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Bright Guard?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Bright Guard

K181099 · Koncept Innovators, LLC · OBR · Jan 18, 2019 · DE

Device Facts

Record ID	K181099
Device Name	Bright Guard
Applicant	Koncept Innovators, LLC
Product Code	OBR · DE
Decision Date	Jan 18, 2019
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Bright Guard is a mouth guard intended to protect against grinding and clenching.

Device Story

Bright Guard is an over-the-counter, flexible, moldable dental mouth guard used as a protective barrier between upper and lower teeth to prevent grinding and clenching. The device is self-fitted by the user via a 'boil and bite' method, where the thermoplastic resin (ethylene-vinyl-acetate) is submerged in hot water to become malleable and then molded to the upper teeth. It is intended for nighttime use by adults. The device is supplied non-sterile and includes a spatula and storage case made of polypropylene. It is a mechanical barrier device; it does not involve electronic processing, software, or clinical decision-making algorithms. The device benefits patients by reducing dental damage and noise associated with bruxism.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including hardness, water sorption, solubility, and boiling/cooling water testing. Biocompatibility was verified per ISO 10993-1, including in vitro cytotoxicity (ISO 10993-5), skin sensitization (ISO 10993-10), and oral mucosal irritation (ISO 10993-10) testing.

Technological Characteristics

Material: 100% Thermoplastic resin Propylene Elastomer (ethylene-vinyl-acetate). Components: Mouth guard, spatula, storage case (polypropylene). Principle: Mechanical barrier, 'boil and bite' custom-fit. Dimensions: One size. Connectivity: None. Sterilization: Non-sterile. Manufacturing: Injection molding. Biocompatibility: Tested per ISO 10993.

Indications for Use

Indicated for adults 18+ years of age for protection against bruxism (teeth grinding) and clenching during sleep.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

GrindGuardN (K133037)

Reference Devices

Rest Assured Extra Comfort Nite Protector Dental Protector (K133423)

Related Devices

K132469 — THE BITE GUARD · International Profit Builders, Inc. · Feb 28, 2014
K240810 — Anti Grinding Guard · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 24, 2024
K222424 — Protect-It Custom Fit Dental Guard · Doc Brands, Inc. · Oct 7, 2022
K231865 — Mouth Guard (ATG0603R) · Reazeal Corp · Nov 6, 2023
K053580 — DOCTOR'S NIGHTGUARD · Dental Concepts, LLC · Mar 3, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |--------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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." {3}------------------------------------------------ # 510(k) Summary for Bright Guard # K181099 Date of 510(k) Summary Preparation: January 15, 2019 - 1. Trade (Proprietary) Name: Bright Guard - 2. Common Name: Mouth Guard, Over-The-Counter #### 3. Contact Information #### Primary [Regulatory Correspondent] | Contact: | Maureen Garner, President New 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 Blvd Suite 170 – 390 Las Vegas, NV 89135 | #### Secondary [Applicant/Sponsor] | Contact: | Sylvan Newby, President Koncept Innovators, LLC. | |----------|---------------------------------------------------------------------------------| | Email: | sylvan@glidegear.com | | Phone: | 843-945-4031 | | Address: | Koncept Innovators, LLC. 1619 Executive Avenue Myrtle 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 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 {4}------------------------------------------------ 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 Extra Comfort Nite Protector Dental Protector | N/A | | 510(k)# | K181099 | K133037 | K133423 | N/A | | Indications for Use | Bright Guard is a mouth guard intended to protect against grinding and clenching. | GrindGuardN is a mouth guard intended to protect against grinding and clenching. | The Rest Assured Extra Comfort Nite Protector Dental Protector is indicated for use for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and to prevent the noise associated with bruxing or grinding. | Both Bright Guard and the predicate provide a barrier between the upper and lower teeth to prevent bruxism. | | Device Description | Flexible, moldable mouth guard used as a barrier between | Flexible, moldable mouth guard used as a barrier between | Flexible, moldable mouth guard used as a barrier between teeth for nighttime teeth grinding | Both Bright Guard and the predicate use moldable "boil and | | | Subject Device | Primary Predicate Device | Reference Device | Similarities and Differences | | | teeth for nighttime teeth grinding. | teeth for nighttime teeth grinding. | | "bite" technology to provide a custom fit. | | Molding Method | Boil and Bite Method (Heat & Bite Self-Fit) | Boil and Bite Method (Heat & Bite Self-Fit) | Boil and Bite Method (Heat & Bite Self-Fit) | Both Bright Guard and the predicate use moldable "boil and bite" technology to provide a custom fit. | | Rx or OTC | OTC | OTC | OTC | Both Bright Guard and the predicate device are indicated for over-the-counter use. | | Method of Manufacturing | Injection Molding | Injection Molding | Injection Molding | Both Bright Guard and the predicate are manufactured by injection molding. | | Biocompatibility | Biocompatible Materials Used | Biocompatible Materials Used | Biocompatible Materials Used | Both Bright Guard and the predicate use biocompatible materials tested according to ISO 10993. | | Sterility | Non-Sterile | Non-Sterile | Non-sterile | Both Bright Guard and the predicate are supplied non-sterile. | | Contact Material | Thermoplastic resin Propylene Elastomer: ethylene-vinyl- acetate [Elvax] No Flavor; No Color Additives | Thermoplastic resin Propylene Elastomer: polycalprolactone No Flavor; No Color Additives | Thermoplastic resin Propylene Elastomer: ethylene-vinyl-acetate [Elvax and Elvaloy] No Flavor; No Color Additives | Both Bright Guard and the predicate are composed of flavorless, colorless thermoplastic elastomer resins designed for dental mouth guards | | Location of Use | Upper Arch Teeth | Upper Arch Teeth | Upper Arch Teeth | Both Bright Guard and the predicate are placed on the upper arch teeth. | | Wear Time | Four (4) months wear time until replacement with new mouth guard Worn during sleeping for no more than twelve (12) hours per day. | Six (6) -eight (8) months wear time until replacement with new mouth guard Not stated on IFU | For more than thee (3) months for initial use without consulting dentist. See dentist every 6 months thereafter while using this product. Not stated in IFU | Bright Guard is worn for 4 months while the predicate can be worn over a 6 to 8 month period. | | Molding Time | In hot water time: 15-20 seconds; Mouth molding time: 20-25 seconds | In hot water time: 10 seconds; Mouth molding time: 20 seconds | 60 seconds in boiling water; 30 seconds to mold in mouth | The predicate has a 10 second shorter boil time and the same bite time to complete molding. | # Comparison of Characteristics {5}------------------------------------------------ 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; {6}------------------------------------------------ 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.