The SleepRight® ProRx® Custom Dental Guard is indicated for the 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.

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 SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.

AI/ML Overview

The provided text describes a 510(k) submission for a dental guard. It does not contain information about a medical device that uses artificial intelligence or requires a study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative evaluation of physical properties, wear and abrasion resistance, and biocompatibility of the SleepRight® ProRx® Custom Dental Guard against predicate devices. The "performance data" section states:

"Comparative evaluation of the physical properties of the materials of construction of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device, the ProTech Dent®."
"Comparative wear and abrasion resistance testing of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device the ProTech Dent®"
"Biocompatibility testing: Cytotoxicity (ISO 10993 - 5), Sensitization and Irritation (ISO 10993 - 10)"

The conclusion states that the device "has the same indications for use, same materials of construction, same technological characteristics, and the same principles of operation as the predicate devices," thereby establishing substantial equivalence.

Given this, I cannot provide the requested information formatted for AI/ML device studies because the provided document does not pertain to such a device or study type. The "acceptance criteria" and "device performance" are focused on material properties and biological safety as compared to predicate devices, not on diagnostic accuracy metrics.

Summary

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November 17, 2017

Splintek, Inc. Samantha Schroeder Research and Development Chemist 15555 West 108th Street Lenexa, Kansas 66219

Re: K172223

Trade/Device Name: SleepRight® ProRx® Custom Dental Guard Regulatory Class: Unclassified Product Code: OBR, MOC Dated: October 18, 2017 Received: October 19, 2017

Dear Samantha Schroeder:

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. 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); 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.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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. Runner -S

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

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Indications for Use

510(k) Number (if known) K172223

Device Name SleepRight® ProRx® Custom Dental Guard

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K172223

Device Name SleepRight® ProRx® Custom Dental Guard

Indications for Use (Describe)

Protection against teeth grinding, bruxism and jaw clenching.

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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II. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

General Information:

A.	Submitted By:	Splintek, Inc.15555 West 108th StreetLenexa, KS 66219Tel: 816-531-2008Fax: 816-531-1968
	Contact Person:	Samantha Schroeder
	Date Prepared	November 16, 2017
B.	Device Trade Name:	SleepRight® ProRx® Custom Dental Guard
	Common Name:	Mouthguard
	Classification Name:	Unclassified (OBR, MQC)
C.	Primary Predicate Device:Reference Predicate Device:	ProTech Dent® (Akervall Technologies, K121272)SleepRight® -Advance (Splintek Inc., K071404)

Device Description: D.
The SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.
E. Performance Data:
The following performance testing was completed for the SleepRight® ProRx® Custom Dental Guard:
. Comparative evaluation of the physical properties of the materials of construction of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device, the ProTech Dent®.

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Comparative wear and abrasion resistance testing of the SleepRight® ProRx® ● Custom Dental Guard and the primary predicate device the ProTech Dent®
Biocompatibility testing
- . Cytotoxicity (ISO 10993 - 5)
- . Sensitization and Irritation (ISO 10993 - 10)
F. OTC Indications for Use:

Prescription Indications for Use:

· Protection against teeth grinding, bruxism and jaw clenching.
· 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.

Element ofComparison	Subject DeviceSleepRight® ProRx®	Primary PredicateProTech Dent®	Reference PredicateSleepRight® -Advance
510(k) Number	K172223	K121272	K071404
PhysicalCharacteristicsMaterial	ThermoplasticPolymer -Polycaprolactone	ThermoplasticPolymer -Polycaprolactone	Elvax StrapPolyurethane andPellethane bite pads.
Method ofManufacture	Injection Molded	Injection Molded	Injection Molded
Rx or OTC	Rx and OTC	OTC	Rx and OTC
Reusable	Yes, singleconsumer.	Yes, singleconsumer.	Yes, single consumer.
Design	Adjustable preformedoral device.	Adjustablepreformed oraldevice.	Partial coverage, preformedoral appliance withadjustable bite pads.

Comparison of Technical Characteristics to Predicate Device: G.

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Element ofComparison	Subject DeviceSleepRight® ProRx®	Primary PredicateProTech Dent®	Reference PredicateSleepRight® -Advance
510(k) Number	K172223	K121272	K071404
Indications forUse	Protection againstbruxism or night timeteeth grinding. It isintended to reducedamage to the teethand to prevent thenoise associated withbruxing or grinding.	The AkervallTechnologiesmouthguards(ProTech Dent®)are indicated for usein protecting theteeth and reducedamage caused bybruxism ornighttime grinding.	Protection against bruxismor nighttime teeth grinding.It is intended to reducedamage to the teeth and toprevent the noise associatedwith bruxing or grinding.
OTC
Rx	Protection against teethgrinding, bruxism & jawclenching.Short-term pain relieffrom muscle spasm due toocclusal interference.For the prevention ofchronic tension andtemporomandibular joint(TMJ) syndrome that iscaused by chronic jawclenching of themandibular and maxillaryteeth by the temporalismuscle.		Protection against teeth grinding,bruxism & jaw clenching.Short-term pain relief frommuscle spasm due to occlusalinterference.For the prevention of chronictension and temporomandibularjoint (TMJ) syndrome that iscaused by chronic jaw clenchingof the mandibular and maxillaryteeth by the temporalis muscle.

H. Conclusion:

The SleepRight® ProRx® Custom Dental Guard has the same indications for use, same materials of construction, same technological characteristics, and the same principals of operation as the predicate devices ProTech Dent® (K121272) and SleepRight® -Advance (K071404). Therefore, the SleepRight® ProRx® Custom Dental Guard is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A