(267 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a simple, moldable mouth guard, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to protect against grinding and clenching, which addresses a medical condition (bruxism) and provides a therapeutic effect by preventing damage to teeth and relieving symptoms associated with grinding.
No
The device is intended to protect against grinding and clenching, acting as a barrier between teeth. It does not perform any diagnostic function.
No
The device description explicitly states that the device is comprised of a mouth guard, spatula, and storage case, which are physical components made of thermoplastic resin and polypropylene. The performance studies also focus on the physical properties and biocompatibility of these materials. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect against grinding and clenching." This is a physical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical mouth guard that acts as a barrier. It does not involve any reagents, analysis of biological samples, or diagnostic procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to detecting diseases, conditions, or markers.
- Performance Studies: The performance studies focus on physical properties (hardness, water sorption/solubility), biocompatibility, and functional testing related to its use as a mouth guard. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Bright Guard is a mouth guard intended to protect against grinding and clenching.
Product codes
OBR
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (specifically upper arch teeth)
Indicated Patient Age Range
at least eighteen (18) years of age
Intended User / Care Setting
Over-The-Counter Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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). 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for Bright Guard
K181099
Date of 510(k) Summary Preparation: January 15, 2019
-
- Trade (Proprietary) Name: Bright Guard
-
- 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 |
-
|
| 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.