(161 days)
· 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
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.
The provided text describes the SleepRight® ProRx® Custom Dental Guard (K193577) and its performance testing for FDA 510(k) clearance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| 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 |
| Comparative Wear and Abrasion Resistance (against DenTek™ Professional-Fit™ Dental Guard) | Not specified (Comparative testing) | The subject device (ProRx) should last an order of magnitude longer than the comparator (Pro-Fit) in "bruxing" cycles. Abrasion results should be comparable to the primary predicate device (K172223). | Yes |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document mentions "biocompatibility testing" and "comparative wear and abrasion resistance testing."
- Biocompatibility Testing: The specific sample sizes for in vitro cytotoxicity, in vivo sensitization, and in vivo irritation are not explicitly stated in the provided text. The provenance is also not specified (e.g., country of origin, retrospective/prospective), but these are typically lab-based tests.
- Comparative Wear and Abrasion Resistance Testing: The sample size for this test is not explicitly stated. The data provenance is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The tests performed are laboratory-based and do not involve expert consensus on subjective interpretations like image analysis.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as the tests are primarily objective laboratory assessments rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study and the effect size of human improvement with AI assistance are not applicable to this device. The SleepRight® ProRx® Custom Dental Guard is a physical dental guard, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Standalone algorithm performance is not applicable to this device, as it is a physical dental guard.
7. The Type of Ground Truth Used:
- Biocompatibility Testing: The ground truth for these tests is established through standardized laboratory procedures and measurements as defined by ISO 10993. This involves observing cell morphology, skin reactions, and irritation scores, which are objective biological responses.
- Comparative Wear and Abrasion Resistance Testing: The ground truth is established through mechanical testing measuring the number of "bruxing" cycles until failure and abrasion results.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable to this device. This is a physical medical device, not an AI or machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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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
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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
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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
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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 StreetLenexa, KS 66219Tel: 816-531-2008Fax: 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.
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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 gradedgreater than 2 is consideredto have a cytotoxic effect | Yes |
| Sensitization ( in vivo ) | ISO 10993-10:2010 | Any skin reaction scoresgreater than the scoresreceived by the negativecontrol group, wereconsidered to representsensitization | Yes |
| Irritation ( in vivo ) | ISO 10993-10:2010 | The requirements are met ifthe difference between thetest article extract averagescore and the controlaverage score is 1.0 or lessand the test does not fail atany observation period | Yes |
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- . 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
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| Element ofComparison | Subject DeviceSleepRight® ProRx®(K193577) | Primary PredicateSleepRight®ProRx™ (K172223) | Reference PredicateProTech Dent®(K121272) |
|---|---|---|---|
| 510(k) Number | K193577 | K172223 | K121272 |
| PhysicalCharacteristicsMaterial | Thermoplastic Polymer-Polycaprolactone | Thermoplastic Polymer-Polycaprolactone | Thermoplastic Polymer -Polycaprolactone |
| Method ofManufacture | 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 oraldevice | Adjustable preformed oraldevice | Adjustable preformed oraldevice |
| Indications for UseOTC | Protection against bruxismor nighttime teethgrinding.Reduce damage to theteeth and to prevent thenoise associated withbruxing or grinding. | Protection against bruxismor night time teethgrinding. It is intended toreduce damage to the teethand to prevent the noiseassociated with bruxing orgrinding. | Protection against bruxismand grinding. Intended toreduce damage to teeth. |
| Rx | Protection against teethgrinding, bruxism, and jawclenching.Short-term pain relief frommuscle spasm due toocclusal interference.Prevention of chronictension andtemporomandibular joint(TMJ) syndrome that iscaused by chronic jawclenching of themandibular and maxillaryteeth by the temporalismuscle. | Protection against teethgrinding, bruxism & jawclenching.Short-term pain relief frommuscle 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. | The device is only intendedfor over-the-counter use; thedevice is not intended forprescription 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.
N/A