Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on physical characteristics and materials, with no mention of AI or ML.

Therapeutic

Yes.
The device is indicated to protect teeth, reduce damage from bruxing or nighttime grinding, and reduce associated noise, which are all therapeutic functions.

Diagnostic

No

Explanation: The device is a bruxism guard intended to protect teeth and reduce damage/noise from grinding. Its stated purpose is not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components (polycarbonate trays, stainless steel T-bar pin, stainless steel slots) and mentions non-clinical testing related to materials and physical characteristics, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the BRX PRO™ Bruxism Guard is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
The BRX PRO™ Bruxism Guard is a physical device that is placed in the mouth to protect teeth and reduce the effects of bruxism. It does not analyze any biological specimens.
Its intended use is to physically protect teeth and reduce noise, not to diagnose or provide information about a medical condition through the analysis of biological samples.

Therefore, the BRX PRO™ Bruxism Guard falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.

Product codes (comma separated list FDA assigned to the subject device)

MQC

Device Description

The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth (oral cavity)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescriber (dentist or physician fitting the patient) for fitting. Patients for night time use.
Home Setting

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)

Non-Clinical Testing
Bench tests included:

Packaging and Assembly / Shipping
Materials Specifications
Labeling Verification
Physical Characteristics

Flexural Modulus: Pass (≥ 2000 MPa)
Flexural Stress: Pass (≥ 65 MPa)
Water Absorption: Pass (≤ 32 µg/m³)
Water Solubility: Pass (≤ 1.6 µg/m³)
Charpy Notched Impact Strength (Linear relation with Fracture): Pass (≥ 0.9 KJ/m²)

Manufacturing
Applicable Standards Met:

ISO 10993-1:2009 COR 1 2010 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process: Pass
ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5 Tests for in vitro cytotoxicity: Pass
ISO 10993-10:2009 Biological Evaluation of Medical Devices - Part 10 Tests for irritation and skin sensitization: Pass
BS EN ISO 15223-1:2012 Medical Devices - Symbols to be used with Medical Devices Labels, Labelling and Information to be supplied- Part 1: General Requirements: Pass
BS EN ISO 20795-1:2013 Dentistry - Base polymers, Part 1: Denture base polymers: Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123161, K111066

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 10, 2015

12th Man Technologies, Inc. Mr. Alex Stenzler President 7245 Garden Grove Blvd., Suite C Garden Grove, California 92841

Re: K151933

Trade/Device Name: BRX PROTM Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: MQC Dated: October 28, 2015 Received: October 30, 2015

Dear Mr. Stenzler:

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. 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.

1

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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 Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):K151933 Device Name: BRX PRO™

Indications for Use:

The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of ___________________________________________________________________________________________________________________________________________________________________

3

510(k) Summary

| Submitter's Name | 12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite G
Garden Grove, CA 92841
1.714.705.4576 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 3009108174 |
| Contact Name | Alex Stenzler
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite G
Garden Grove, CA 92841
Telephone: 1.714.705.4576
Fax: 1.714.373.0505
Email: alex.stenzler@12thmantec.com |
| Date Prepared | December 10, 2015 |
| Device Trade Name | BRX PRO™ |
| Device Common Name | Bruxism guard |
| Classification Name | None |
| Product Code | MQC |
| Device Classification | Unclassified |
| Panel | Dental |
| 510(k) Submission | Traditional |
| Legally Marketed Equivalent | SmartGuard (K123161)
Brux-TMD QuickSplint (K111066) |

Description

The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.

4

The impression materials that can be used to interface with the teeth are any of the approved for sale materials such as Mousse PVS (Parkell), individually selected by the dentist or physician fitting the patient with the BRX PRO and are typically a polyvinyl siloxane (PVS) available from many dental supply sources.

Predicate Devices

The design of the BRX PRO is substantially equivalent to the SmartGuard (K123161) and the Brux-TMD QuickSplint (K111066). The predicate devices are mouth guards designed to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reduce the noise associated with bruxing and grinding. The Brux-TMD QuickSplint uses thermoplastic arches filled with impression material to interface to the teeth. The impression material is the same PVS as recommended for use in the BRX PRO and can be fitted in a prescriber's office. The BRX PRO Instructions-for-Use recommends that the dentist or prescriber uses commercially available polyvinyl siloxane impression materials to create the tray liner to obtain the ideal fit. Because these mouth guards can be used on either the upper or lower teeth, some dentists prescribe that the patient use mouth guards on both arches. The SmartGuard, Brux-TMD QuickSplint and the BRX PRO all use partial arches to create a posterior arch air gap.

Description of Operation

The BRX PRO comes with two sets of trays. A pair of impression trays (upper and lower) are sequentially filled with a PVS impression material by the prescriber to fit to the patient. Once trimmed by the dentist, the impressions are transferred to the treatment trays. The upper tray has a "T-bar" pin that extends out from the bottom of the tray. The pin has an anterior or posterior orientation so that when combined with the two slots in the lower tray, provides for a selection of four positions to fit the patient who may have a natural bite ranging from a Class III as well as an edge-to-edge bite position. The "T-bar" pin is inserted into the slot and rotated 90 degrees to connect the two trays. The slots provide for lateral movement of the mandible.

Indications for Use:

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

5

Substantial Equivalency Summary Comparison Table
Element of
Comparison	BRX PRO™	SmartGuard	Brux-TMD QuickSplint
Indications for
Use	To protect the teeth and
reduce damage caused
by bruxing or nighttime
grinding and reducing
the noise associated
with bruxing and
grinding.	To reduce damage to the
teeth and reduce noise
associated with bruxing
and/or grinding	Prevent teeth grinding,
reduces jaw clenching and
damage to teeth
Regulatory	Pre-Market Notification
510(k)	K123161	K111066
Environment
of Use	Home Setting	Home Setting	Home Setting
Design	Custom fitted mouth
guard	Custom fitted mouth
guard	Custom fitted mouth
guard
Use	Night time	Night time	Night time
Daily Duration
of Use	Up to 8 hours per night
for up to 30 days	Up to 12 hours per 24
hour period	While asleep and limited
daytime use
Transitional
Device	Yes	NA	Yes
Reusable	Yes, Single Patient	Yes, Single Patient	Yes, Single Patient
Sterile	No	No	No
Method of
disinfection	Denture cleaner	Denture cleaner	Soap and water
Tray Materials	Polycarbonate and
stainless steel	Elvax (ethylene vinyl
acetate copolymer)	Polycarbonate
Tray
manufacturing
method	Injection molded	Injection molded	Injection molded
Impression
Material	Prescriber selected and
supplied PVS	Elvax (ethylene vinyl
acetate copolymer)	Prescriber selected and
supplied PVS

6

Non-Clinical Testing

Non-clinical test results are submitted to confirm product conformance with device requirements and substantial equivalence to predicate device. These bench tests included:

1. Packaging and Assembly / Shipping
1. Materials Specifications
1. Labeling Verification
1. Physical Characteristics

| Physical Parameter | Test Method | ISO 20795-1:2013
Requirement | Pass/Fail |
|----------------------------------------------------------------------|-------------|---------------------------------|-----------|
| Flexural Modulus | ISO 178 | ≥ 2000 MPa | Pass |
| Flexural Stress | ISO 178 | ≥ 65 MPa | Pass |
| Water Absorption | ISO 62 | ≤ 32 µg/m³ | Pass |
| Water Solubility | ISO 62 | ≤ 1.6 µg/m³ | Pass |
| Charpy Notched Impact
Strength (Linear relation
with Fracture) | ISO 179 | ≥ 0.9 KJ/m² | Pass |

1. Manufacturing

Applicable Standards Met
Standard or
Regulation	Standard
Organization or
Regulatory
Body	Name of Test Performed	Test
Results
ISO 10993-
1:2009 COR 1
2010	International
Standards Office	Biological Evaluation of Medical
Devices - Part 1: Evaluation and
Testing within a Risk Management
Process	Pass
ISO 10993-
5:2009	International
Standards Office	Biological Evaluation of Medical
Devices – Part 5 Tests for in vitro
cytotoxicity	Pass
ISO 10993-
10:2009	International
Standards Office	Biological Evaluation of Medical
Devices - Part 10 Tests for irritation
and skin sensitization	Pass
BS EN ISO
15223-1:2012	International
Standards Office	Medical Devices - Symbols to be used
with Medical Devices Labels,
Labelling and Information to be
supplied- Part 1: General
Requirements	Pass
BS EN ISO
20795-1:2013	International
Standards Office	Dentistry - Base polymers, Part 1:
Denture base polymers	Pass

7

Substantial Equivalence

Based on the design, intended use, principle of operation, technological characteristics, performance data, and attribute comparison above, the 12th Man Technologies, Inc. BRX PRO bruxism guard is substantially equivalent to the currently marketed predicate devices which have been previously reviewed for market clearance by the FDA.

[510(k)] Number