(190 days)
No
The device description and performance studies focus on the physical properties and manufacturing process of a mouth guard, with no mention of AI or ML technologies.
No.
The device acts as a physical barrier to prevent damage from grinding and clenching, but it does not actively treat or cure the underlying condition causing the grinding and clenching, nor does it deliver any therapeutic agents. Its primary function is protective.
No
The device is described as a protective barrier (mouth guard) to prevent teeth grinding and clenching, not to diagnose a condition.
No
The device description clearly states it is a "mouth guard" and describes physical characteristics and manufacturing processes, indicating it is a physical device, not software.
Based on the provided information, the FBCC Night Guard is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "protection of teeth and restorations against grinding and clenching." This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description reinforces its function as a "mouth guard used as a barrier between teeth."
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on durability and manufacturing accuracy, which are relevant to a physical device, not a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The FBCC Night Guard does not perform any of these functions.
N/A
Intended Use / Indications for Use
The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
Product codes
OBR
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Worn on maxillary or mandibular teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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
1
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
2
Indications for Use
510(k) Number (if known)
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 602 |
| Los Angeles, CA 90045 | |
| Phone: | (323) 596-6459 |
| Email: | pablosorio6@gmail.com |
| Submission Correspondent: | Elisabeth Miller, Regulatory Affairs Consultant |
| Address: | 1321 Upland Dr. Suite 6792 |
| Houston, 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:
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).
Indications for Use:
The FBCC Night Guard is indicated for protections against grinding and clenching and clenching.
5
Comparison to Predicate Devices:
| Specification | Subject Device:
FBCC Night
Guard | Predicate
Device:
Bright Guard
(K181099) | Reference Device:
JS Dental Lab Mouth
Guard
(K210011) | Comparison
Result |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Product Code | OBR | OBR | MQC | Same as
predicate |
| Classification
Panel | Dental | Dental | Dental | Same |
| Device Class | Unclassified | Unclassified | Unclassified | Same |
| OTC or Rx | ОТС | OTC | RX | Same as
predicate |
| Material | Thermoplastic
Polyurethane or
Ethylene-
Vinylacetate | Thermoplastic
resin Propylene
Elastomer:
ethylene-
vinylacetate
[Elvax] No Flavor;
No Color
Additives | Thermoplastic
Polyurethane, Ethyl Vinyl
acetate (Erkodur or Splint
Biocryl, Erkoloc-Pro,
Erkoflex-95, EVA Based
Clear Mouthguard
Material and BIOPLAST) | Similar |
| Method of
Manufacturing | Thermoforming | Injection
Molding | Thermoforming | Same as
reference |
| Anatomical Sites | Worn on
maxillary or
mandibular teeth | Worn on
maxillary teeth | Worn on maxillary or
mandibular teeth | Same as
reference |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Device
Description | The FBCC Night
Guard is a mouth
guard used as a
barrier between
teeth for
nighttime teeth
grinding by
creating physical
separation
between upper | Flexible,
moldable mouth
guard used as a
barrier between
teeth for
nighttime teeth
grinding. | The JS Dental Lab Mouth
Guard (herein referred to
as Subject Device) is a
patient contact protective
custom-fit mouth guard
that covers the upper
teeth and lower teeth to
prevent premature tooth
wear and noise caused
due to bruxism and teeth | Similar |
| | | | | |
| | and lower tooth
surfaces
preventing tooth
damage caused
by bruxism (e.g.,
grinding and
clenching). | | grinding. It fits over upper
teeth or lower teeth
during sleep. The Subject
Device 510(k) Summary
K210011Ampower Dental
Laboratories LLC
Confidential Page 3 of 6 Al
response for K210011 can
offset the effects of
bruxing or teeth grinding
while protecting teeth
from daily wear and tear.
The Subject Device is
created based on the
user's teeth impression
and manufactured using
the biocompatible
material, equivalent to the
Thermoformed
Mouthguards/Nightguards
(herein referred to as
Predicate Device,
K121365). The Subject
Device contains
biocompatible materials,
namely, Erkodur or Splint
Biocryl, Erkoloc-Pro,
Erkoflex-95, EVA Based
Clear Mouthguard
Material and BIOPLAST
and is available in four
different variations. All
the biocompatible
materials used are ISO-
certified, BPA-free, and
are cleared for dental use
in humans. | |
| Patient
Removable? | Yes | Yes | Yes | Same |
| Indication for
Use | The FBCC Night
Guard is
indicated for
protection of
teeth and
restorations
against | Bright Guard is a
mouth guard
intended to
protect against
grinding and
clenching. | The Subject Device (The JS
Dental Mouth Guard) is
intended for protection
against bruxism and teeth
grinding. They create a
barrier between the upper | Similar |
| | grinding and
clenching. | | protect the patient's
overall occlusion. | |
| Mechanism of
Action | Disocclusion | Disocclusion | Disocclusion | Same |
Table 1. Predicate and Reference Device Comparison
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7
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.
8
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).