(113 days)
No
The description focuses on the mechanical design and materials of a dental guard for bruxism, with no mention of AI or ML capabilities.
Yes
The device is indicated for protection against bruxism, teeth grinding, and jaw clenching, and for short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporomandibular joint (TMJ) syndrome, which are all therapeutic benefits.
No
The device is a dental guard designed for protection against bruxism and teeth grinding, and for pain relief and prevention of TMJ syndrome. Its purpose is therapeutic/protective, not to diagnose a condition.
No
The device description clearly describes a physical dental guard with adjustable bite pads and a thermal band, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SleepRight® Select-Comfort™ Dental Guard is a physical device worn in the mouth to protect teeth from grinding and clenching. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "protection against bruxism or nighttime teeth grinding," "reduce damage to the teeth," and "prevent the noise associated with bruxing or grinding." These are mechanical or physical functions, not diagnostic ones.
- Device Description: The description details the physical components and how it fits in the mouth. There is no mention of any diagnostic capabilities or analysis of biological material.
Therefore, the SleepRight® Select-Comfort™ Dental Guard is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SleepRight® Select-Comfort™ 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.
The SleepRight® Select-Comfort™ Dental Guard is indicated for the 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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, OBR
Device Description
The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard is a self-adjustable partial coverage protector that acts as a barrier between the upper and lower posterior teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains two adjustable bite pads that are connected by a thermal band (also referred to as the strap). The bite pads contain an internal core that is fully encapsulated by a thermoplastic material; and can be adjusted in five settings: extra-small, small, medium, large, and extra-large. No boiling or microwaving is required to fit the guard to the teeth, it is ready for use right out of the package. The bite pads may be adjusted to five settings that accommodate different dental arch sizes, where the front edge of the bite pad should rest between the upper third tooth (cuspid) and the fourth tooth (premolar). For a larger fit, the bite pads can be adjusted backward; and for a smaller fit, the bite pads can be adjusted forward. The thermal band should rest between the lower lip, cheek, and gums.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Comparative evaluation in the materials of construction and physical properties for the subject device, the SleepRight® Select-Comfort™ Dental Guard: the primary predicate device, the SleepRight® Low Profile (K071404); and the reference device, the SleepRight® Original (K100545).
- The subject device, the primary predicate device (K071404), and the reference device (K100545) all contain an internal bite pad core comprised of materials that are suitable to maintain the structural integrity needed for the bite pad to be overmolded and to provide protection to the teeth during bruxism, thus the subject device is substantially equivalent to both predicate devices.
- The subject device and the reference device (K100545) both contain the exact same thermoplastic material that encapsulates the internal bite pad core, thus both devices are substantially equivalent.
- The subject device, the primary predicate device (K071404), and the reference device (K100545) all contain a thermal band (also referred to as the strap) comprised of the exact same materials that are suitable to maintain the structural integrity needed to secure the bite pads to the strap, thus the subject device is substantially equivalent to both predicate devices.
- Biocompatibility testing of the subject device, the SleepRight® Select-Comfort™ Dental Guard. The biocompatibility testing supports that the subject device satisfies the biocompatibility testing acceptance criteria and is substantially equivalent to both predicate devices.
- Cytotoxicity (in vitro) per ISO 10993-5:2009: Acceptance Criteria Met.
- Sensitization (in vivo) per ISO 10993-10:2010: Acceptance Criteria Met.
- Irritation (in vivo) per ISO 10993-23:2021: Acceptance Criteria Met.
- Comparative wear and abrasion resistance testing of the subject device, the SleepRight® Select-Comfort™ Dental Guard (Select) and the DenTekTM Professional-Fit™ Dental Guard (Pro-Fit).
- The longevity of both guards was evaluated by comparing the number of "bruxing" cycles that the guards could withstand before failure. The data demonstrated that the Select lasted 4 times longer than the Pro-Fit.
- The abrasion results are comparable in the subject device and in the primary predicate device (K071404), as they both lasted longer than the Pro-Fit and are therefore substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SleepRight® Low Profile (Splintek Inc., K071404)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SleepRight® Original (Splintek Inc., K100545)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
December 22, 2021
Splintek, Inc. Thomas Brown Chief Executive Officer (CEO) of Splintek, Inc. 15555 West 108th Street Lenexa, Kansas 66219
Re: K212767
Trade/Device Name: SleepRight Select-Comfort Dental Guard Regulatory Class: Unclassified Product Code: MQC, OBR Dated: September 22, 2021 Received: September 24, 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/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 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
2
Indications for Use
510(k) Number (if known) K212767
Device Name SleepRight® Select-Comfort™ Dental Guard
Indications for Use (Describe)
The SleepRight® Select-Comfort™ 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)
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
"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) K212767
Device Name SleepRight® Select-Comfort™ Dental Guard
Indications for Use (Describe)
The SleepRight® Select-Comfort™ Dental Guard is indicated for the 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 (TMI) 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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) information is submitted in accordance with 21 CFR 807.92.
General Information (K212767):
| 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 | August 27, 2021 |
| B. | Device Trade Name: | SleepRight® Select-Comfort™ Dental Guard |
| | Common Name: | Mouthguard |
| | Classification Name: | Unclassified (OBR, MQC) |
| C. | Primary Predicate Device: | SleepRight® Low Profile (Splintek Inc., K071404) |
| | Reference Device: | SleepRight® Original (Splintek Inc., K100545) |
- D. Device Description:
The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard is a self-adjustable partial coverage protector that acts as a barrier between the upper and lower posterior teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains two adjustable bite pads that are connected by a thermal band (also referred to as the strap). The bite pads contain an internal core that is fully encapsulated by a thermoplastic material; and can be adjusted in five settings: extra-small, small, medium, large, and extra-large. No boiling or microwaving is required to fit the guard to the teeth, it is ready for use right out of the package. The bite pads may be adjusted to five settings that accommodate different dental arch sizes, where the front edge of the bite pad should rest between the upper third tooth (cuspid) and the fourth tooth (premolar). For a larger fit, the bite pads can be adjusted backward; and for a smaller fit, the bite pads can be adjusted forward. The thermal band should rest between the lower lip, cheek, and gums.
5
-
E. Performance Data:
The following performance testing was completed for the subject device, the SleepRight® Select-Comfort™ Dental Guard: -
Comparative evaluation in the materials of construction and physical . properties for the subject device, the SleepRight® Select-Comfort™ Dental Guard: the primary predicate device, the SleepRight® Low Profile (K071404); and the reference device, the SleepRight® Original (K100545).
- The subject device, the primary predicate device (K071404), and the o reference device (K100545) all contain an internal bite pad core comprised of materials that are suitable to maintain the structural integrity needed for the bite pad to be overmolded and to provide protection to the teeth during bruxism, thus the subject device is substantially equivalent to both predicate devices.
- The subject device and the reference device (K100545) both contain o the exact same thermoplastic material that encapsulates the internal bite pad core, thus both devices are substantially equivalent.
- The subject device, the primary predicate device (K071404), and the o reference device (K100545) all contain a thermal band (also referred to as the strap) comprised of the exact same materials that are suitable to maintain the structural integrity needed to secure the bite pads to the strap, thus the subject device is substantially equivalent to both predicate devices.
-
Biocompatibility testing of the subject device, the SleepRight® Select-● Comfort™ Dental Guard. See the biocompatibility testing acceptance criteria below stating that the subject device is biocompatible. The biocompatibility testing supports that the subject device satisfies the biocompatibility testing acceptance criteria and is substantially equivalent to both predicate devices.
6
| 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 10993-23:2021 | 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 device, the SleepRight® Select-Comfort™ Dental Guard (Select) and the DenTekTM Professional-Fit™ Dental Guard (Pro-Fit).
- o The longevity of both guards was evaluated by comparing the number of "bruxing" cycles that the guards could withstand before failure. The data demonstrated that the Select lasted 4 times longer than the Pro-Fit.
- The abrasion results are comparable in the subject device and in the o primary predicate device (K071404), as they both lasted 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 of Comparison | Subject Device SleepRight® Select-Comfort™ | Primary Predicate SleepRight® Low Profile (K071404) | Reference Device SleepRight® Original (K100545) |
|---|---|---|---|
| 510(k) Number | K212767 | K071404 | K100545 |
| Physical Characteristics Material | Ethylene vinyl acetate and polyethylene strap; polypropylene and thermoplastic elastomer bite pads | Ethylene vinyl acetate and polyethylene band; thermoplastic polyurethane bite pads | Ethylene vinyl acetate and polyethylene band; polypropylene bite pads |
| 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 | Partial coverage, pre-formed oral appliance with adjustable bite pads that do not articulate. No boiling required. | Partial coverage, pre-formed oral appliance with adjustable bite pads that articulate. No boiling required. | Partial coverage, pre-formed oral appliance with adjustable bite pads that do not articulate. No boiling required. |
| 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 or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. |
| 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 TMJ 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 Device: G.
8
Conclusion H.
The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard has 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® Low Profile (K071404) and the reference device, the SleepRight® Original (K100545). Therefore, the SleepRight® Select-Comfort™ Dental Guard is substantially equivalent to the predicate devices.