(161 days)
K Den No: K121272
No
The device description and performance studies focus on the physical properties and materials of a custom-formable dental guard, with no mention of AI or ML technology.
Yes.
The device's intended uses, such as providing "short-term pain relief from muscle spasm due to occlusal interference" and "prevention of chronic tension and temporomandibular joint (TMJ) syndrome," indicate that it is intended to cure, mitigate, treat, or prevent a disease or condition, which aligns with the definition of a therapeutic device.
No
This device is a dental guard designed to protect against bruxism and teeth grinding, and to provide pain relief. It does not identify, assess, or monitor a disease or condition.
No
The device description clearly states it is a physical dental guard made of moldable thermoplastic material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are focused on protecting teeth from grinding, reducing damage, preventing noise, providing short-term pain relief from muscle spasms, and preventing chronic tension and TMJ syndrome. These are all related to the mechanical interaction and protection of oral structures.
- Device Description: The device is described as a physical barrier that is custom-formed to the teeth. It works by creating a physical separation between the upper and lower teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples to gain diagnostic information. This device is a physical appliance used in the mouth to prevent mechanical damage and alleviate symptoms related to bruxism.
N/A
Intended Use / 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
- 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 (comma separated list FDA assigned to the subject device)
OBR, MQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, mandibular and maxillary teeth
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 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) 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.
- 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). The biocompatibility testing supports that the subject device (K193577) satisfies the biocompatibility testing acceptance criteria and is substantially equivalent to both predicate devices.
- 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 "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.
- 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.
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.
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.
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
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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
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)
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.