← Product Code OBR · K172223 # SleepRight ProRx Custom Dental Guard (K172223) _Splintek, Inc. · OBR · Nov 17, 2017 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K172223 ## Device Facts - **Applicant:** Splintek, Inc. - **Product Code:** OBR - **Decision Date:** Nov 17, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use 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 Story SleepRight® ProRx® is a full-occlusal, custom-formable dental guard providing a physical barrier between upper and lower teeth. Device consists of a hard core enveloped by moldable thermoplastic (polycaprolactone). User heats guard in hot water, inserts into mouth, and manually molds side walls to upper teeth; material hardens in approximately one minute. Used by consumers (OTC) or patients (Rx) to protect against bruxism, teeth grinding, and jaw clenching; also provides short-term pain relief from muscle spasms and helps prevent chronic tension/TMJ syndrome. Device is reusable by a single consumer. ## Clinical Evidence No clinical data. Evidence consists of bench testing: comparative physical property evaluation (tensile strength, Shore D hardness), comparative wear and abrasion resistance testing against ProTech Dent®, and biocompatibility testing (cytotoxicity per ISO 10993-5; sensitization and irritation per ISO 10993-10). ## Technological Characteristics Material: Polycaprolactone thermoplastic polymer. Form factor: Adjustable preformed oral device. Manufacturing: Injection molded. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation). Tensile strength: 29 MPa. Reusable by single consumer. ## Regulatory Identification To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. ## Predicate Devices - ProTech Dent® ([K121272](/device/K121272.md)) - SleepRight® -Advance ([K071404](/device/K071404.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172223 Device Name SleepRight® ProRx® Custom Dental Guard #### Indications for Use (Describe) 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. | 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." {3}------------------------------------------------ ## 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.* 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." {4}------------------------------------------------ # 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 Street
Lenexa, KS 66219
Tel: 816-531-2008
Fax: 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®. {5}------------------------------------------------ - 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: 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. 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 of
Comparison | Subject Device
SleepRight® ProRx® | Primary Predicate
ProTech Dent® | Reference Predicate
SleepRight® -Advance | |-----------------------------------------|------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------| | 510(k) Number | K172223 | K121272 | K071404 | | Physical
Characteristics
Material | Thermoplastic
Polymer -
Polycaprolactone | Thermoplastic
Polymer -
Polycaprolactone | Elvax Strap
Polyurethane and
Pellethane bite pads. | | Method of
Manufacture | Injection Molded | Injection Molded | Injection Molded | | Rx or OTC | Rx and OTC | OTC | Rx and OTC | | Reusable | Yes, single
consumer. | Yes, single
consumer. | Yes, single consumer. | | Design | Adjustable preformed
oral device. | Adjustable
preformed oral
device. | Partial coverage, preformed
oral appliance with
adjustable bite pads. | - Comparison of Technical Characteristics to Predicate Device: G. {6}------------------------------------------------ | Element of
Comparison | Subject Device
SleepRight® ProRx® | Primary Predicate
ProTech Dent® | Reference Predicate
SleepRight® -Advance | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K172223 | K121272 | K071404 | | Indications for
Use | Protection against
bruxism or night time
teeth grinding. It is
intended to reduce
damage to the teeth
and to prevent the
noise associated with
bruxing or grinding. | The Akervall
Technologies
mouthguards
(ProTech Dent®)
are indicated for use
in protecting the
teeth and reduce
damage caused by
bruxism or
nighttime grinding. | 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. | | OTC | | | | | Rx | Protection against teeth
grinding, bruxism & 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. | | Protection against teeth grinding,
bruxism & 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. | ## 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. --- **Source:** [https://fda.innolitics.com/device/K172223](https://fda.innolitics.com/device/K172223) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com