OTC: Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching. Rx: Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

Device Description

The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.

AI/ML Overview

The provided document is a 510(k) summary for a dental device, the "Freeway Comfort™ Bite Guard." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the document focuses on:

Device Description: What the device is made of and how it works.
Intended Use/Indications for Use: The medical conditions the device is designed to address.
Predicate Devices: Identifying similar devices already on the market.
Substantial Equivalence Argument: Explaining why the new device is as safe and effective as the predicate devices, despite minor technological differences.

Based on the provided text, I cannot extract the following information:

A table of acceptance criteria and the reported device performance: This type of data is not included in this substantial equivalence document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described.
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): No ground truth establishment for a test set is discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as there is no test set.
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: This is not an AI device, and no such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device, and no such performance evaluation is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in the context of device performance testing.
The sample size for the training set: There is no mention of a training set as this is not an AI/software device undergoing performance training.
How the ground truth for the training set was established: Not applicable, as there is no training set described.

In summary, the provided document is a regulatory submission for substantial equivalence, not a scientific study detailing performance data against predefined acceptance criteria.

Summary

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110468 RANDMARK DENTAL PRODUCTS LLC

284 Elkins Ln. Lusby, MD 20657

(410) 326-6235

AUG - 5 2011

SECTION 5.0

SUMMARY OF SAFETY & EFFECTIVENESS

This summary of 510 (k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92.

1 5.1

Sponsor Identification 5.1.1

.............................................................................................................................................................................. Randmark Dental Products LLC 284 Elkins Ln Lusby, MD 20657 Tel: 410-326-6235 Fax: 501-637-7204 ..............................................................................................................................................................................

Sponsor/Manufacturer Establishment Registration Number: NA 5.1.2

Submission Correspondent 5.13 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Norman F. Estrin, Ph.D. Managing Partner ESTRIN CONSULTING GROUP LLC 9109 Copenhaver Drive Potomac, MD 20854 Tel: (301) 279-2899 Fax:(301) 294-0126 estrin(a)yourFD.A.consultans.com ..............................................................................................................................................................................

5.2

000016

00005

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KII 0468

Device Trade Names 5.3

.............................................................................................................................................................................

..............................................................................................................................................................................

Model Numbers 5.3.1

5.3.2 -

Not currently available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Common Name: Dental Guard

..............................................................................................................................................................................

Classification Name: None . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3.3
Regulation Numbers: None 5.3.4 .........

Proposed Regulation Class: unclassified 5.3.5 -

Device Product Code: OBR, MQC 5.3.6 ...
Medical Specialties: Dental 5.3.7 5.4 Device Description

5.5 INDICATIONS FOR USE No T ON OOE

OTC:

Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Protection against teeth grinding, bruxism and jaw clenching.

Rx:

Short-term pain relief from muscle spasm due to occlusal interference.

For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the

temporalis muscle.

000017

00006

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PREDICATE DEVICES 5.6

Predicate Devices: SleepRight Products listed below (K071404) (Applicant: Power 5.61 Products. Inc. - Splintek)
NTI Tension Suppression System (K010876)(Applicant: NTI-TSS, Inc.)
5.62
.
............................................................................................................................................................................

5.6.3	Product Code	Predicate Device Names:
	OBR	SleepRight® -Select
	OBR	SleepRight®-Low Profile
	OBR	SleepRight®-Advance
	OCO	NTI Tension Suppression System
	MQC	SleepRight® - Low Profile Rx
	MQC	SleepRight® - Advance Rx
	OCO	NTI Tension Suppression System

SUBSTANTIAL EQUIVALENCE 5.7 -----

OTC: The Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the three above listed SleepRight products under Product code OBR. The Freeway Comfort™ Bite Guard mouth guard has the same intended uses, indications and similar technological characteristics as its predicate devices. The minor technological differences between the Freeway Comfort™ Bite Guard mouth guard and the predicate devices raise no new questions of safety or effectiveness. Thus, the Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the three SleepRight® products and the NTI product noted above.

Rx: The Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the two SleepRight products shown above with the Product Code MQC. The Freeway Comfort" Bite Guard mouth guard has the same intended uses, indications and similar technological characteristics as its predicate devices. The minor technological differences between the Freeway Comfort™ Bite Guard mouth guard and the predicate devices raises no new questions of safety or effectiveness. Thus, the Freeway Comfort" Bite Guard mouth guard is substantially equivalent to the above noted two SleepRight products with the Product Code MQC and the NTI Tension Suppression System with the Product Code OCO. Note that the Freeway Comfort" Bite Guard mouth guard is not claiming substantial equivalence to the NTI Tension Suppression System for either OTC or Rx uses for the NTI migraine treatment claims.

000019 00008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

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

Randmark Dental Products, LLC C/O Norman F. Estrin, Ph.D. Managing Partner Estrin Consulting Group, LLC 9109 Copenhaver Drive Potomac, Maryland 20854

AUG - 5 2011

Re: K110468

Trade/Device Name: Freeway Comfort™ Bite Guard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC, OBR Dated: July 28, 2011 Received: July 29, 2011

Dear Dr. Estrin:

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.

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Page 2 – Dr. Estrin

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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4.0 Indications for Use

510(k) Number (if known): K110468 Device Name: Freeway Comfort™ Bite Guard

Indications for Use:

OTC:

Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Protection against teeth grinding, bruxism and jaw clenching.

Rx:

Short-term pain relief from muscle spasm due to occlusal interference.

For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

Prescription Use	X	AND/OR	Over-The-Counter Use	X
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Page __ of __
Division of Anesthesiology, General HospitalInfection Control, Dental Devices	00001400004
510(k) Number:	K110468

Regulation Number and Section

N/A