Protection against bruxism or nighttime teeth grinding
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
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 subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) are the second-generation quard to the SleepRight® ProRx™ Custom Dental Guard (K172223). Both subject devices (K212706) are completely identical to each other, except for the material that makes up the internal core of each guard. The subject devices (K212706) are both a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The subject devices (K212706) both contain the exact same horizontal core design with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material in both guards. The guards are designed to be fit using the exact same method to heat the guard in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

AI/ML Overview

The provided text describes performance testing for the SleepRight® ProRx® + Custom Dental Guard and SleepRight® ProRx® Custom Dental Guard.

Here's an analysis of the acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

Test Performed	Standard	Acceptance Criteria	Reported Performance
Material Properties
Tensile Strength	ASTM D638	Not explicitly stated, but "Yes" implies meeting a predefined threshold.	Yes
Flexural Strength	ASTM D790	Not explicitly stated, but "Yes" implies meeting a predefined threshold.	Yes
Flexural Modulus	ASTM D790	Not explicitly stated, but "Yes" implies meeting a predefined threshold.	Yes
Elongation	ASTM D638	Not explicitly stated, but "Yes" implies meeting a predefined threshold.	Yes
Shore D Hardness	ASTM D2240	Not explicitly stated, but "Yes" implies meeting a predefined threshold.	Yes
Biocompatibility
Cytotoxicity (in vitro)	ISO 10993-5:2009	Cell morphology graded greater than 2 is considered to have a cytotoxic effect.	Yes (Implies cell morphology was graded 2 or less)
Sensitization (in vivo)	ISO 10993-10:2010	Any skin reaction scores greater than the scores received by the negative control group were considered to represent sensitization.	Yes (Implies skin reaction scores were not greater than negative control)
Irritation (in vivo)	ISO 10993-10:2010, ISO 10993-23:2021	The requirements are met if the difference between the test article extract average score and the control average score is 1.0 or less and the test does not fail at any observation period.	Yes (Implies these conditions were met)
Wear and Abrasion Resistance
Longevity against "bruxing" cycles	Not explicitly stated, implied to be a comparative metric.	Not explicitly stated as a numerical criterion, but the subject devices should demonstrate comparable or superior performance to predicate devices.	Both subject devices lasted an order of magnitude longer than the DenTek™ Professional-Fit™ Dental Guard (Pro-Fit). Abrasion results were comparable to the primary and reference predicate devices.

Study Details

The provided text describes several types of studies performed, primarily comparative evaluations.

Sample size used for the test set and the data provenance:
- Material Properties (Tensile Strength, Flexural Strength, Flexural Modulus, Elongation, Shore D Hardness): The document reports that these tests were performed on "the subject devices" and "predicate devices." No specific sample sizes for these tests are mentioned. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective).
- Biocompatibility (Cytotoxicity, Sensitization, Irritation): No specific sample sizes (e.g., number of cell lines, animal subjects) are given. The provenance of the data is not specified.
- Wear and Abrasion Resistance: The "longevity of the guards was evaluated by comparing the number of 'bruxing' cycles that the guards could withstand before failure." No specific sample size (i.e., number of guards tested) is provided. The provenance of the data is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the involvement of experts for establishing ground truth in any of the described tests. The tests appear to be laboratory-based evaluations against established standards (ASTM, ISO) or comparative performance evaluations, where the "ground truth" is defined by the test procedure itself (e.g., cytotoxicity grade, skin reaction score, number of bruxing cycles to failure).
Adjudication method:
- Not applicable as no human assessment or consensus-based ground truth establishment is described.
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:
- An MRMC study is not relevant here as the device is a dental guard, not an AI-assisted diagnostic or decision support system for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The reported performance refers to the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For material properties and biocompatibility, the "ground truth" is defined by the validated testing methodologies and acceptance criteria specified in international standards (ASTM, ISO).
- For wear and abrasion resistance, the "ground truth" is defined by the number of "bruxing" cycles to failure observed during the test, with comparative analysis against other devices.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2021

Splintek, Inc. Thomas Brown Chief Executive Officer (CEO) of Splintek, Inc. 15555 West 108th Street Lenexa, Kansas 66219

Re: K212706

Trade/Device Name: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard Regulatory Class: Unclassified Product Code: OBR, MQC Dated: November 08, 2021 Received: November 12, 2021

Dear Thomas Brown:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

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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510(k) Number (if known) K212706

Device Name SleepRight® ProRx® + Custom Dental Guard

Indications for Use (Describe)

· Protection against bruxism or nighttime teeth grinding

· Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding

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)

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

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510(k) Number (if known) K212706

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
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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON SEPARATE PAGE

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

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510(k) Number (if known) K212706

Device Name SleepRight® ProRx® Custom Dental Guard

Indications for Use (Describe)

· Protection against bruxism or nighttime teeth grinding

· Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding

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)

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

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510(k) Number (if known) K212706

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED

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

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K212706

II. 510(k) Summary

This summary of 510(k) 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:	Thomas W. Brown
	Date Prepared:	December 2, 2021
B.	Device Trade Name:	SleepRight® ProRx® + Custom Dental Guard (K212706)SleepRight® ProRx® Custom Dental Guard (K212706)
	Common Name:	Mouthguard
	Classification Name:	Unclassified (OBR, MQC)
C.	Primary Predicate Device:	SleepRight® ProRx® Custom Dental Guard (Splintek IncK193577)
	Reference Predicate Device:	SleepRight® ProRx™ Custom Dental Guard (Splintek IncK172223)

D. Device Description:

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E. Performance Data:

The following performance testing was completed for the subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706):

Comparative evaluation in the materials of construction for the subject devices, the ● SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706); the primary predicate device, the SleepRight® ProRx® Custom Dental Guard (K193577): and the reference predicate device, the SleepRight® ProRx™ Custom Dental Guard (K172223). See the tests performed below.
- The subject devices (K212706), the primary predicate device (K193577), o and the reference predicate device (K172223) all contain an internal core comprised of materials that are suitable to maintain the structural integrity needed to be overmolded, to withstand the hot (not boiling) water during the fitting process, and to provide protection to the teeth during bruxism; thus, both subject devices are substantially equivalent to both predicate devices.
- The subject devices (K212706), the primary predicate device (K193577), o and the reference predicate device (K172223) all contain the same moldable thermoplastic material that incapsulates the internal core, thus both subject devices are substantially equivalent to both predicate devices.

Test Performed	Standard	Acceptance Criteria Met
Tensile Strength	ASTM D638	Yes
Flexural Strength	ASTM D790	Yes
Flexural Modulus	ASTM D790	Yes
Elongation	ASTM D638	Yes
Shore D Hardness	ASTM D2240	Yes

Biocompatibility testing of the subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706). See the biocompatibility testing acceptance criteria below stating that the subject devices (K212706) are biocompatible. The biocompatibility testing supports that both subject devices satisfy the biocompatibility testing acceptance criteria and are substantially equivalent to both predicate devices.

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Test Performed	Standard	Acceptance Criteria	Acceptance Criteria Met
Cytotoxicity (in vitro)	ISO 10993-5:2009	Cell morphology graded greater than 2 is considered to have a cytotoxic effect	Yes
Sensitization (in vivo)	ISO 10993-10:2010	Any skin reaction scores greater than the scores received by the negative control group, were considered to represent sensitization	Yes
Irritation (in vivo)	ISO 10993-10:2010ISO 10993-23:2021	The requirements are met if the difference between the test article extract average score and the control average score is 1.0 or less and the test does not fail at any observation period	Yes

Comparative wear and abrasion resistance testing of the subject devices, the ● SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706); and the DenTek™ Professional-Fit™ Dental Guard (Pro-Fit).
- The longevity of the guards was evaluated by comparing the number of o "bruxing" cycles that the guards could withstand before failure. The data demonstrated that both subject devices (K212706) lasted an order of magnitude longer than the Pro-Fit.
- The abrasion results in the subject devices (K212706) are comparable to the о primary predicate device (K193577) and to the reference predicate device (K172223) as all subject devices and predicate devices lasted an order of magnitude longer than the Pro-Fit and are therefore substantially equivalent.
F. Over-the-Counter (OTC) Indications for Use:
- Protection against bruxism or nighttime teeth grinding
- Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding

Prescription (Rx) Indications for Use:

. Protection against teeth grinding, bruxism, and jaw clenching
Short-term pain relief from muscle spasm due to occlusal interference
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

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Element ofComparison	Subject DeviceSleepRight® ProRx® +(K212706)	Subject DeviceSleepRight® ProRx®(K212706)	Primary PredicateSleepRight® ProRx®(K193577)	Reference PredicateSleepRight® ProRx™(K172223)
510(k) Number	K212706	K212706	K193577	K172223
PhysicalCharacteristicsMaterial	ThermoplasticPolymer-Polycaprolactone	ThermoplasticPolymer-Polycaprolactone	Thermoplastic Polymer-Polycaprolactone	Thermoplastic Polymer-Polycaprolactone
Method ofManufacture	Injection Molded	Injection Molded	Injection Molded	Injection Molded
OTC or Rx	OTC and Rx	OTC and Rx	OTC and Rx	OTC and Rx
Reusable	Yes, single consumer	Yes, single consumer	Yes, single consumer	Yes, single consumer
Design	Adjustable pre-formedoral device	Adjustable pre-formedoral device	Adjustable pre-formedoral device	Adjustable pre-formedoral device
Indications forUseOTC	Protection againstbruxism or nighttimeteeth grinding.	Protection againstbruxism or nighttimeteeth grinding.	Protection againstbruxism or nighttimeteeth grinding.	Protection againstbruxism or night timeteeth grinding. It isintended to reduce
	Reduce damage to theteeth and to prevent thenoise associated withbruxing or grinding.	Reduce damage to theteeth and to preventthe noise associatedwith bruxing orgrinding.	Reduce damage to theteeth and to prevent thenoise associated withbruxing or grinding.	damage to the teeth andto prevent the noiseassociated with bruxingor grinding.
Rx	Protection against teethgrinding, bruxism, andjaw clenching.Short-term pain relieffrom muscle spasm dueto occlusal interference.Prevention of chronictension andtemporomandibularjoint (TMJ) syndromethat is caused bychronic jaw clenchingof the mandibular and	Protection againstteeth grinding,bruxism, and jawclenching.Short-term pain relieffrom muscle spasmdue to occlusalinterference.Prevention of chronictension andtemporomandibularjoint (TMJ) syndromethat is caused bychronic jaw clenchingof the mandibular andmaxillary teeth by thetemporalis muscle.	Protection against teethgrinding, bruxism, andjaw clenching.Short-term pain relieffrom muscle spasm dueto occlusal interference.Prevention of chronictension andtemporomandibular joint(TMJ) syndrome that iscaused by chronic jawclenching of themandibular andmaxillary teeth by thetemporalis muscle.	Protection against teethgrinding, bruxism & jawclenching.Short-term pain relieffrom muscle spasm dueto occlusal interference.For the prevention ofchronic tension andtemporomandibular joint(TMJ) syndrome that iscaused by chronic jawclenching of themandibular andmaxillary teeth by thetemporalis muscle.
	maxillary teeth by thetemporalis muscle.

Comparison of Technical Characteristics to Predicate Device: G.

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H. Conclusion

The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) are the second-generation guard to the SleepRight® ProRx™ Custom Dental Guard (K172223). The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) have the same indications for use, similar materials of construction, same technological characteristics, and the same principals of operation as the primary predicate device, the SleepRight® ProRx® Custom Dental Guard (K193577) and the reference predicate device, the SleepRight® ProRx™ Custom Dental Guard (K172223). Therefore, both subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

N/A