Who is the manufacturer of SleepRight ProRx Custom Dental Guard?

Splintek, Inc. filed the 510(k) submission for SleepRight ProRx Custom Dental Guard (K193577).

What is the FDA product code for SleepRight ProRx Custom Dental Guard?

OBR. as a Class U device in the DE panel.

What is the regulatory pathway for SleepRight ProRx Custom Dental Guard?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SleepRight ProRx Custom Dental Guard?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SleepRight ProRx Custom Dental Guard

Q: What are the predicate devices for SleepRight ProRx Custom Dental Guard?

SleepRight ProRx Custom Dental Guard (K172223).

K193577 · Splintek, Inc. · OBR · Jun 1, 2020 · DE

Device Facts

Record ID	K193577
Device Name	SleepRight ProRx Custom Dental Guard
Applicant	Splintek, Inc.
Product Code	OBR · DE
Decision Date	Jun 1, 2020
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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 Story

SleepRight ProRx Custom Dental Guard is a second-generation, full-occlusal, custom-formable oral appliance; acts as a physical barrier between upper and lower teeth. Device features a horizontal core with a vertical sectional lattice structure, encapsulated in moldable thermoplastic material (polycaprolactone). User heats device in hot water until malleable; inserts into mouth; manually molds side walls/lattice against upper teeth; device hardens in approximately four minutes. Used by consumers for protection against bruxism, teeth grinding, and jaw clenching; also used for short-term pain relief from muscle spasms and prevention of TMJ syndrome. Device is reusable by a single consumer. No electronic components or software.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity per ISO 10993-5, sensitization and irritation per ISO 10993-10) and comparative wear/abrasion resistance testing against the DenTek Professional-Fit Dental Guard. Results showed the subject device lasted an order of magnitude longer than the comparator.

Technological Characteristics

Material: Polycaprolactone thermoplastic polymer. Design: Adjustable preformed oral device with horizontal core and vertical sectional lattice. Manufacturing: Injection molded. Biocompatibility: Compliant with ISO 10993-5 and ISO 10993-10. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring protection against bruxism, nighttime teeth grinding, and jaw clenching; relief of short-term muscle spasm due to occlusal interference; and prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching.

Regulatory Classification

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

SleepRight ProRx Custom Dental Guard (K172223)

Reference Devices

ProTech Dent (K121272)
DenTek Professional-Fit Dental Guard

Related Devices

K172223 — SleepRight ProRx Custom Dental Guard · Splintek, Inc. · Nov 17, 2017
K222424 — Protect-It Custom Fit Dental Guard · Doc Brands, Inc. · Oct 7, 2022
K133037 — GRINDGUARD · Grind Guard Technologies, LLC · Jan 23, 2014
K053580 — DOCTOR'S NIGHTGUARD · Dental Concepts, LLC · Mar 3, 2006
K133423 — REST ASSURED EXTRA COMFORT NITE PROTECTOR · Ranir, LLC · Dec 20, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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. June 1, 2020 Splintek, Inc. Thomas Brown Chief Executive Officer (CEO) of Splintek, Inc. 15555 West 108th Street Lenexa, Kansas 66219 Re: K193577 Trade/Device Name: SleepRight ProRx Custom Dental Guard Regulatory Class: Unclassified Product Code: OBR, MQC Dated: April 22, 2020 Received: April 24, 2020 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/cfpmp/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 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 {1}------------------------------------------------ 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 medical devices and radiation-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, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K193577 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) [ 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 I he burden instructions, search existing data sources, gather and maintain the data needed and complete time to 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301)-419-419-409-4040 EF {3}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K193577 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) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ## 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 The burden time for this ources, gather and maintain the data into leaders and complete of ony other aspect 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publicating Soprices (J01)-413-6748 {4}------------------------------------------------ ## K193577 # 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 Street Lenexa, KS 66219 Tel: 816-531-2008 Fax: 816-531-1968 | |----|-----------------------------|---------------------------------------------------------------------------------------------------------| | | Contact Person: | Thomas W. Brown | | | Date Prepared | May 8, 2020 | | B. | Device Trade Name: | SleepRight® ProRx® Custom Dental Guard (K193577) | | | Common Name: | Mouthguard | | | Classification Name: | Unclassified (OBR, MQC) | | C. | Primary Predicate Device: | SleepRight® ProRx™ Custom Dental Guard (Splintek, Inc. K172223) | | | Reference Predicate Device: | ProTech Dent® (Akervall Technologies, K121272) | - D. Device Description: The SleepRight® ProRx® Custom Dental Guard (K193577) is the second-generation guard to the predicate SleepRight® ProRx™ Custom Dental Guard (K172223). The SleepRight® ProRx® Custom Dental Guard (K193577) is 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 guard contains a horizontal core 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. The guard is heated 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. {5}------------------------------------------------ #### E. Performance Data: The following performance testing was completed for the subject device, the SleepRight® ProRx® Custom Dental Guard (K193577): - Comparative evaluation in the materials of construction for the subject device, the . SleepRight® ProRx® Custom Dental Guard (K193577) and the primary predicate device, the SleepRight® ProRx™ Custom Dental Guard (K172223). - The subject device (K193577) and the primary predicate device (K172223) O both contain an internal core comprised of materials that are suitable to maintain the structural integrity needed to withstand the hot (not boiling) water during the fitting process, thus both devices are substantially equivalent. - o The subject device (K193577) and the primary predicate device (K172223) both contain the exact same moldable thermoplastic material that incapsulates the internal core, thus both devices are substantially equivalent. - Biocompatibility testing of the subject device, the SleepRight® ProRx® Custom . Dental Guard (K193577). See the biocompatibility testing acceptance criteria below stating that the subject device (K193577) is biocompatible. The biocompatibility testing supports that the subject device (K193577) satisfies the biocompatibility testing acceptance criteria and is substantially equivalent to both predicate devices. | 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 10993-10:2010 | 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 | {6}------------------------------------------------ - . Comparative wear and abrasion resistance testing of the subject device, the SleepRight® ProRx® Custom Dental Guard (ProRx) (K193577) and the DenTek™ Professional-Fit™ Dental Guard (Pro-Fit). - The longevity of both guards were evaluated by comparing the number of o "bruxing" cycles that the guards could withstand before failure. The data demonstrated that the ProRx lasted an order of magnitude longer than the Pro-Fit. - o The abrasion results are comparable in the subject device (K193577) and in the primary predicate device (K172223) as they both lasted an order of magnitude longer than the Pro-Fit and are therefore substantially equivalent. - Over-the-Counter (OTC) Indications for Use: F. - . 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 {7}------------------------------------------------ | Element of Comparison | Subject Device SleepRight® ProRx® (K193577) | Primary Predicate SleepRight® ProRx™ (K172223) | Reference Predicate ProTech Dent® (K121272) | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | 510(k) Number | K193577 | K172223 | K121272 | | Physical Characteristics Material | Thermoplastic Polymer- Polycaprolactone | Thermoplastic Polymer- Polycaprolactone | Thermoplastic Polymer - Polycaprolactone | | Method of Manufacture | Injection Molded | Injection Molded | Injection Molded | | OTC or Rx | OTC and Rx | OTC and Rx | OTC | | Reusable | Yes, single consumer | Yes, single consumer | Yes, single consumer | | Design | Adjustable preformed oral device | Adjustable preformed oral device | Adjustable preformed oral device | | Indications for Use OTC | Protection against bruxism or nighttime teeth grinding. Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. | 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. | Protection against bruxism and grinding. Intended to reduce damage to teeth. | | Rx | 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. | 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. | The device is only intended for over-the-counter use; the device is not intended for prescription use. | - Comparison of Technical Characteristics to Predicate Devices: G. #### H. Conclusion The subject device, the SleepRight® ProRx® Custom Dental Guard (K193577) is the secondgeneration guard to the predicate SleepRight® ProRx™ Custom Dental Guard (K172223). The SleepRight® ProRx® Custom Dental Guard (K193577) has the same indications for use, similar materials of construction, same technological characteristics, and the same principals of operation as the predicate device SleepRight® ProRx™ Custom Dental Guard (K172223) and ProTech Dent® (K121272). Therefore, the subject device, the SleepRight® ProRx® Custom Dental Guard (K193577) is substantially equivalent to both predicate devices.