The FBCC Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

AI/ML Overview

This document describes an FDA 510(k) clearance for the FBCC Night Guard. It is a submission that declares the device is "substantially equivalent" to predicate devices, meaning it does not introduce new questions of safety or effectiveness. As such, the information provided focuses on demonstrating this equivalence rather than detailing an extensive clinical study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets, expert-established ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of regulatory submission, as the FBCC Night Guard is a physical medical device (a mouth guard), not an AI-powered diagnostic or therapeutic device.

However, I can extract the relevant information regarding the performance testing that was conducted to support its substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Since this is a physical device and a 510(k) submission based on substantial equivalence, there are no "acceptance criteria" in the traditional sense of a specified performance metric (e.g., accuracy, sensitivity, specificity) for an AI algorithm. Instead, the "acceptance criteria" were implied to be the demonstration of similarity to legally marketed predicate devices and satisfactory non-clinical performance.

Criterion Type	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Device must be substantially equivalent to a legally marketed predicate device, demonstrating similar indications for use, technological characteristics, and safety/effectiveness without raising new questions of safety or effectiveness.	The FBCC Night Guard was found substantially equivalent to the Bright Guard (K181099) and the JS Dental Lab Mouth Guard (K210011). Similarities were established in: - Product Code (OBR)- Classification Panel (Dental)- Device Class (Unclassified)- OTC or Rx (OTC, same as predicate)- Anatomical Sites (maxillary or mandibular teeth)- Sterile (Non-Sterile)- Patient Removable (Yes)- Mechanism of Action (Disocclusion)- Indications for Use (protection of teeth and restorations against grinding and clenching).
Material Safety	Material must be suitable for its intended use and not introduce new risks.	The FBCC Night Guard uses Thermoplastic Polyurethane or Ethylene-Vinylacetate. The predicate uses Thermoplastic resin (Propylene Elastomer: ethylene-vinylacetate [Elvax]). The submission states: "While these are not identical polymers, each material is a known dental thermoplastic polymer with similar characteristics. The use of thermoplastic polyurethane does not introduce or reduce any risks when compared to the other."
Manufacturing Process	Manufacturing process must be appropriate and not introduce new risks.	The FBCC Night Guard is Thermoforming. The predicate (Bright Guard) is Injection Molding, and the reference device (JS Dental Lab Mouth Guard) is Thermoforming. The submission states: "While these are not identical processes, both are commonly used to create mouth guards and other dental devices... The use of thermoforming does not increase the risk associated with manufacturing." An internal manufacturing validation demonstrated "dimensional accuracy of the manufacturing process" and "robustness of the process... from 3D printing through thermoforming."
Durability Testing	Must demonstrate suitability for the intended period of use under simulated real-world conditions.	"Durability testing was completed on these night guards. Real world use was simulated to ensure that the Night Guard material and manufacturing process produced Night Guards that were suitable for the intended period of use." (Specific quantitative results or "acceptance criteria" for durability are not provided in this summary document, but the statement indicates it passed this internal testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as there was no AI test set with case data. The testing mentioned (durability, manufacturing validation) would be internal laboratory testing on physical prototypes/products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical mouth guard, not an AI diagnostic/imaging device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No AI test set or clinical image review was performed for this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As a physical device submission focused on substantial equivalence, the "ground truth" for the claims rested on:

Comparison of specifications to legally marketed predicate devices.
Results of non-clinical, mechanical, and material testing (e.g., durability, dimensional validation).
Scientific literature supporting the use of the materials and mechanism of action for night guards.

8. The sample size for the training set

Not applicable. There is no AI model or training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI model or training set.

Summary of the Study Proving the Device Meets Criteria (Based on Provided Document):

The "study" proving the device met the criteria for 510(k) clearance was primarily a demonstration of substantial equivalence to existing predicate devices already on the market. This involved:

Comparison of Technical Characteristics: A detailed comparison table (Table 1) was presented, highlighting similarities in product code, classification, device class, OTC status, anatomical sites, sterility, patient removability, indications for use, and mechanism of action with the Bright Guard (K181099) and JS Dental Lab Mouth Guard (K210011).
Material Equivalence: Although different specific polymers (thermoplastic polyurethane vs. thermoplastic resin), the submission argued both are "known dental thermoplastic polymer with similar characteristics" and introduce no new risks.
Manufacturing Process Equivalence: While the subject device uses thermoforming and the primary predicate uses injection molding, the submission highlighted that thermoforming is also used by the reference device and is a "commonly used" method that "does not increase the risk."
Non-Clinical Performance Testing:
- Durability Testing: Simulated real-world use was conducted to ensure the night guards were suitable for the intended period of use. (Specific quantitative results were not detailed in this summary).
- Manufacturing Validation: An internal validation was performed to check the dimensional accuracy and robustness of the manufacturing process (3D printing through thermoforming).
Conclusion: Based on these comparisons and non-clinical tests, the FDA determined the FBCC Night Guard to be "substantially equivalent" to the predicate devices, and therefore, no clinical studies were deemed necessary to demonstrate its safety and effectiveness.

Summary

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November 18, 2022

FBCC Inc % Elisabeth Miller Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K221369

Trade/Device Name: FBCC Night Guard Regulatory Class: Unclassified Product Code: OBR Dated: September 19, 2022 Received: September 19, 2022

Dear Elisabeth Miller:

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 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

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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 (QS) 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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT 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)

K221369

Device Name FBCC Night Guard

Indications for Use (Describe)

The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5. 510(k) Summary K221369

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:	FBCC Inc
Company Contact Person:	Pablo Osorio
Address:	6711 S Sepulveda Blvd, Unit 602Los Angeles, CA 90045
Phone:	(323) 596-6459
Email:	pablosorio6@gmail.com
Submission Correspondent:	Elisabeth Miller, Regulatory Affairs Consultant
Address:	1321 Upland Dr. Suite 6792Houston, TX 77043
Phone:	(586) 242-7718
Email:	emiller@primepathmedtech.com
Date Prepared:	November 2022
Proprietary Name:	FBCC Night Guard
Common Name:	Mouth Guard
Product Code:	OBR
Device Classification:	Unclassified
Predicate Device:	Bright Guard
Reference Device:	JS Dental Lab Mouth Guard

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Device Description:

Indications for Use:

The FBCC Night Guard is indicated for protections against grinding and clenching and clenching.

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Comparison to Predicate Devices:

Specification	Subject Device:FBCC NightGuard	PredicateDevice:Bright Guard(K181099)	Reference Device:JS Dental Lab MouthGuard(K210011)	ComparisonResult
Product Code	OBR	OBR	MQC	Same aspredicate
ClassificationPanel	Dental	Dental	Dental	Same
Device Class	Unclassified	Unclassified	Unclassified	Same
OTC or Rx	ОТС	OTC	RX	Same aspredicate
Material	ThermoplasticPolyurethane orEthylene-Vinylacetate	Thermoplasticresin PropyleneElastomer:ethylene-vinylacetate[Elvax] No Flavor;No ColorAdditives	ThermoplasticPolyurethane, Ethyl Vinylacetate (Erkodur or SplintBiocryl, Erkoloc-Pro,Erkoflex-95, EVA BasedClear MouthguardMaterial and BIOPLAST)	Similar
Method ofManufacturing	Thermoforming	InjectionMolding	Thermoforming	Same asreference
Anatomical Sites	Worn onmaxillary ormandibular teeth	Worn onmaxillary teeth	Worn on maxillary ormandibular teeth	Same asreference
Sterile	Non-Sterile	Non-Sterile	Non-Sterile	Same
DeviceDescription	The FBCC NightGuard is a mouthguard used as abarrier betweenteeth fornighttime teethgrinding bycreating physicalseparationbetween upper	Flexible,moldable mouthguard used as abarrier betweenteeth fornighttime teethgrinding.	The JS Dental Lab MouthGuard (herein referred toas Subject Device) is apatient contact protectivecustom-fit mouth guardthat covers the upperteeth and lower teeth toprevent premature toothwear and noise causeddue to bruxism and teeth	Similar

	and lower toothsurfacespreventing toothdamage causedby bruxism (e.g.,grinding andclenching).		grinding. It fits over upperteeth or lower teethduring sleep. The SubjectDevice 510(k) SummaryK210011Ampower DentalLaboratories LLCConfidential Page 3 of 6 Alresponse for K210011 canoffset the effects ofbruxing or teeth grindingwhile protecting teethfrom daily wear and tear.The Subject Device iscreated based on theuser's teeth impressionand manufactured usingthe biocompatiblematerial, equivalent to theThermoformedMouthguards/Nightguards(herein referred to asPredicate Device,K121365). The SubjectDevice containsbiocompatible materials,namely, Erkodur or SplintBiocryl, Erkoloc-Pro,Erkoflex-95, EVA BasedClear MouthguardMaterial and BIOPLASTand is available in fourdifferent variations. Allthe biocompatiblematerials used are ISO-certified, BPA-free, andare cleared for dental usein humans.
PatientRemovable?	Yes	Yes	Yes	Same
Indication forUse	The FBCC NightGuard isindicated forprotection ofteeth andrestorationsagainst	Bright Guard is amouth guardintended toprotect againstgrinding andclenching.	The Subject Device (The JSDental Mouth Guard) isintended for protectionagainst bruxism and teethgrinding. They create abarrier between the upper	Similar
	grinding andclenching.		protect the patient'soverall occlusion.
Mechanism ofAction	Disocclusion	Disocclusion	Disocclusion	Same

Table 1. Predicate and Reference Device Comparison

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Comparison of Indications for Use to Predicate Device:

The indications for use are similar for the subject and reference devices. The subject and predicate devices are indicated for the protection of teeth against grinding and clenching.

Comparison of Technological Features to Predicate Devices:

The FBCC Night Guard uses the same mechanism of action as the predicate product. It is intended to be worn on the teeth to protect teeth against grinding and clenching.

As summarized above, the main differences between the subject device (FBCC Night Guard) and predicate device (Bright Guard):

Material
Method of Manufacturing ●

Overall, the differences are minor and do not impact risk to the patient or user of the product.

Material

The subject device is manufactured using thermoplastic polyurethane, whereas the predicate device is manufactured using a thermoplastic resin. While these are not identical polymers, each material is a known dental thermoplastic polymer with similar characteristics. The use of thermoplastic polyurethane does not introduce or reduce any risks when compared to the other.

Method of Manufacturing

The subject device is thermoformed while the predicate device is injection molded. While these are not identical processes, both are commonly used to create mouth guards and other dental devices. The subject and reference device (JS Dental Lab Mouth Guard) both use thermoforming as the method of manufacturing. The use of thermoforming does not increase the risk associated with manufacturing.

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Non-Clinical Performance Testing

The use of thermoplastic materials Night Guards indicated for protection of teeth against grinding and bruxing has been well documented in scientific literature. However, durability testing was completed on these night guards. Real world use was simulated to ensure that the Night Guard material and manufacturing process produced Night Guards that were suitable for the intended period of use.

An internal manufacturing validation was performed to test the dimensional accuracy of the manufacturing process for the FBCC Night Guards. The robustness of the process was demonstrated from 3D printing through thermoforming.

Clinical Performance Testing

The technological characteristics, indications for use, material, and manufacturing and processes are the same or similar to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.

Conclusion

Based on the similarities in indications for use, technological characteristics, and nonclinical performance testing the FBCC Night Guards are substantially equivalent to the predicate device Bright Guard (K181099).

Regulation Number and Section

N/A