(109 days)
No
The device description and performance studies focus on the physical materials and mechanical properties of the dental guard, with no mention of AI or ML technology.
Yes.
The device is intended to provide protection against bruxism and teeth grinding, reduce pain from muscle spasms, and prevent TMJ syndrome, which are all therapeutic purposes.
No
The device is described as 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" and provides "short-term pain relief from muscle spasm due to occlusal interference" and "prevention of chronic tension and temporomandibular joint (TMJ) syndrome." Its intended use and device description focus on protecting teeth and relieving symptoms, not on diagnosing conditions.
No
The device description clearly states it is a "full occlusal custom formable protector" made of physical materials (internal core, lattice, moldable thermoplastic material) that acts as a physical barrier. It is a physical dental guard, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a dental guard designed to be placed in the mouth to protect teeth from grinding and clenching. It acts as a physical barrier.
- Intended Use: The intended uses listed are all related to physical protection and pain relief within the mouth and jaw, not the analysis of biological samples.
- Device Description: The description focuses on the physical construction and fitting process of the guard.
- Performance Studies: The performance studies described involve comparative evaluation of materials, biocompatibility, and wear/abrasion resistance – all related to the physical properties and safety of the device in the mouth.
There is no mention of analyzing biological samples or providing diagnostic information based on such analysis. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
OBR, MQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, jaw, temporomandibular joint (TMJ)
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)
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).
- The subject devices (K212706), the primary predicate device (K193577), 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), 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.
- Tests Performed: Tensile Strength (ASTM D638), Flexural Strength (ASTM D790), Flexural Modulus (ASTM D790), Elongation (ASTM D638), Shore D Hardness (ASTM D2240). All met acceptance criteria.
-
Biocompatibility testing of the subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706). The biocompatibility testing supports that both subject devices satisfy the biocompatibility testing acceptance criteria and are substantially equivalent to both predicate devices.
- Tests Performed: Cytotoxicity (in vitro) (ISO 10993-5:2009), Sensitization (in vivo) (ISO 10993-10:2010), Irritation (in vivo) (ISO 10993-10:2010, ISO 10993-23:2021). All met acceptance criteria.
-
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 "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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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
1
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
2
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
3
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.
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
4
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
5
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.
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
6
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 Street
Lenexa, KS 66219
Tel: 816-531-2008
Fax: 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 Inc
K193577) |
| | Reference Predicate Device: | SleepRight® ProRx™ Custom Dental Guard (Splintek Inc
K172223) |
D. 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.
7
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.
8
| 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 | ||
| 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 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
9
| Element of
Comparison | Subject Device
SleepRight® ProRx® +
(K212706) | Subject Device
SleepRight® ProRx®
(K212706) | Primary Predicate
SleepRight® ProRx®
(K193577) | Reference Predicate
SleepRight® ProRx™
(K172223) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212706 | K212706 | K193577 | K172223 |
| Physical
Characteristics
Material | Thermoplastic
Polymer-
Polycaprolactone | Thermoplastic
Polymer-
Polycaprolactone | Thermoplastic Polymer-
Polycaprolactone | Thermoplastic Polymer-
Polycaprolactone |
| Method of
Manufacture | 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-formed
oral device | Adjustable pre-formed
oral device | Adjustable pre-formed
oral device | Adjustable pre-formed
oral device |
| Indications for
Use
OTC | Protection against
bruxism or nighttime
teeth grinding. | Protection against
bruxism or nighttime
teeth grinding. | Protection against
bruxism or nighttime
teeth grinding. | Protection against
bruxism or night time
teeth grinding. It is
intended to reduce |
| | Reduce damage to the
teeth and to prevent the
noise associated with
bruxing or grinding. | Reduce damage to the
teeth and to prevent
the noise associated
with bruxing or
grinding. | Reduce damage to the
teeth and to prevent the
noise associated with
bruxing or grinding. | 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 | 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, 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. |
| | maxillary teeth by the
temporalis muscle. | | | |
Comparison of Technical Characteristics to Predicate Device: G.
10
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.