(156 days)
None
No
The device description details a physical dental night guard made of thermoplastic material, with no mention of software, data processing, or AI/ML algorithms.
Yes
The device is described with both OTC and Rx indications for use, including relief of headaches and pains, temporary treatment of Temporal Mandibular Disorder (TMD), and prevention of chronic tension and TMJ syndrome, which are all therapeutic benefits.
No
The device description and intended use indicate that the SmartGuard® is a dental night guard designed to treat rather than diagnose conditions like bruxism and teeth grinding by preventing tooth occlusion and relaxing jaw muscles.
No
The device description clearly states that the SmartGuard® is a dental night guard composed of Elvax, a thermoplastic material, and describes its physical design and how it is worn on the teeth. This indicates it is a physical medical device, not software-only.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SmartGuard® is a physical dental appliance designed to be worn in the mouth to prevent teeth grinding and clenching. It works by physically separating the teeth and relaxing jaw muscles.
- Intended Use: The intended uses listed (protection against bruxism, reducing damage, pain relief, temporary TMD treatment) are all related to the physical action of the device within the mouth, not the analysis of biological specimens.
- Device Description: The description focuses on the material, molding process, and how it fits and functions within the oral cavity. There is no mention of analyzing any bodily fluids or tissues.
Therefore, the SmartGuard® falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OTC:
- Protection against bruxism or night time teeth grinding ♥
- Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.
Rx: - Protection of teeth grinding, bruxism, and jaw clenching. o
- Protection of restorations from injury due to bruxism or clenching. o
- Relief of bruxism related headaches and pains. .
- Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of . chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated o headaches and pains.
Product codes
MQC, OBR
Device Description
The SmartGuard® is a dental night guard composed of Elvax and once this thermoplastic material is submerged in hot water (see molding instructions) it softens and conforms to the individual's anterior maxillary teeth from first bicuspid. SmartGuard® is designed to be worn on the anterior, upper 6 to 8 teeth, preventing the posterior teeth from coming into occlusion, which relaxes the jaw muscles and helps to reduce jaw clenching and grinding and reduces the associated symptoms. The lower bottom anterior teeth bite against the bottom of the substrate with the ability to slide around freely as the device reduces posterior teeth cuspal interferences. The design features of SmartGuard® allow patients to easily mold this device at home or in a prescribing office, to fit their teeth properly. The SmartGuard® is designed to be worn at night and not longer than 12 consecutive hours in a 24 hour period.
SmartGuard® Original and SmartGuard Elite® differ slightly in design, with the primary difference being in the width of the palatal ex-tension, (Original 21mm and Elite 30 mm) as well as the distance between the outer rim and mesial/occlusal surface of the palatal extension (Original 10 mm and Elite 9 mm). The SmartGuard Elite® was designed to fit the majority of individuals mouths. However, if the patient has a small mouth or has a sensitive gag reflex, the SmartGuard® Original might be a better fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior maxillary teeth, anterior, upper 6 to 8 teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or in a prescribing office
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SleepRight Products (K071404 and K022809), NTI Tension Suppression System (K010876 & K981546), Freeway Comfort Bite Guard (K110468), GrindGuardn (K082723), Brux-TMD QuickSplint (K111066), Doctor's Night Guard (K073220)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAR. 1 4 2013
.HUMPHREY&ASSOCIATESPA
CHRISTINE M. HUMPHREY, ESO CHUMPHREY OCHPALAW.CO ITTED IN FLORIDA
501 BRICKELL KEY DRIV SUITE 104 MIAMI. FLORIDA 33131 P: 305.372.2421 : 305.372.7983
W.CHPALAW.COM
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 C.F.R. 807.92.
General Information
A. Submitted By:
Dr. David L. Spainhower, DDS SmartGuard, Inc. 2360 Corporate Circle, Suite 400 Henderson, NV 89074
Contact Person:
Date Prepared:
B. Device Trade Name:
Common Name:
Classification Name:
C. Predicate Devices: (SleepRight -
Dr. David L. Spainhower
August 24, 2012
SmartGuard® Night Guard, SmartGuard® Original, SmartGuard® Night Guard Original and SmartGuard Elite"
Dental Guard/Night Guard/Mouth Guard
Unclassified
SleepRight Products (K071404 and K022809)
Select; SleepRight - Low Profile; SleepRight -Advance; SleepRight - Low Profile Rx, Advance Rx)
NTI Tension Suppression System (K010876 & K981546)
Freeway Comfort Bite Guard (K110468)
GrindGuardn (K082723)
Brux-TMD QuickSplint (K111066)
Doctor's Night Guard (K073220)
.
1
August 28, 2012 Page 2 of 3
D. Device Description:
SmartGuard® The SmartGuard® is a dental night guard composed of Elvax and once this thermoplastic material is submerged in hot water (see molding instructions) it softens and conforms to the individual's anterior maxillary teeth from first bicuspid. SmartGuard® is designed to be worn on the anterior, upper 6 to 8 teeth, preventing the posterior teeth from coming into occlusion, which relaxes the jaw muscles and helps to reduce jaw clenching and grinding and reduces the associated symptoms. The lower bottom anterior teeth bite against the bottom of the substrate with the ability to slide around freely as the device reduces posterior teeth cuspal interferences. The design features of SmartGuard® allow patients to easily mold this device at home or in a prescribing office, to fit their teeth properly. The SmartGuard® is designed to be worn at night and not longer than 12 consecutive hours in a 24 hour period.
SmartGuard® Original and SmartGuard Elite® differ slightly in design, with the primary difference being in the width of the palatal ex-tension, (Original 21mm and Elite 30 mm) as well as the distance between the outer rim and mesial/occlusal surface of the palatal extension (Original 10 mm and Elite 9 mm). The SmartGuard Elite® was designed to fit the majority of individuals mouths. However, if the patient has a small mouth or has a sensitive gag reflex, the SmartGuard® Original might be a better fit.
OTC:
- Protection against bruxism or night time teeth grinding
- . Intended to reduce damage to the teeth and reduce noise associated with bruxing and/or grinding.
Rx:
- . Protection of teeth grinding, bruxism, and jaw clenching.
- . Protection of restoration from injury due to bruxism or clenching.
- . Relief of bruxism related headaches and pains.
- . Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular joint (TMI) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of . associated headaches and pains.
2
E. Comparison of Technical Characteristics of Predicate Devices
See Attachment Comparison of predicate devices
OTC:
The SmartGuard® devices are substantially equivalent to the SleepRight Select, SleepRight Low Profile, SleepRight Advance (cleared under K071404) and Freeway Comfort Bite Guard (K110468) with product code OBR. SmartGuard® is substantially equivalent to the above indicated devices cleared under the referenced 510K numbers. SmartGuard® is identical in design and material to the OTC devices cleared under K071404 and K110468. It has the same intended uses, indications, and similar technological characteristics as its predicate devices. The minor technological differences between SmartGuard® and the predicate devices raise no new questions of safety or effectiveness. Thus, SmartGuard® is substantially equivalent to the above referenced products and product code OBR noted above.
Rx:
The SmartGuard® devices are also substantially equivalent to SleepRight Low Profile Rx, SleepRight Advance Rx, Freeway Comfort Bite Guard, GrindGuardn and Brux-TMD QuickSplint with product code MQC. SmartGuard® has the same intended uses, indications and similar technological characteristics as its predicate devices. The minor technological differences between SmartGuard® and the predicate devices raise no new questions of safety or effectiveness. Thus, SmartGuard® is substantially equivalent to the above referenced products with the Product Code MOC.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
SmartGuard, Incorporated C/O Ms. Shelly Garg Attorney Humphrey & Associates, P.A. 601 Brickell Key Drive, Suite 104 MIAMI FL 33131
Re: K123161
Trade/Device Name: SmartGuard® Night Guard, SmartGuard® Original, SmartGuard® Night Guard Original and SmartGuard Elite™
Regulation Number: Unclassified Regulation Name: Prescription Mouthguard Regulatory Class: Unclassified Product Code: MQC, OBR Dated: January 10, 2013 Received: February 12, 2013
Dear Ms. Garg:
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. 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.
4
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the text "Kwame O. Ulmer for" in a simple, sans-serif font. The name "Kwame" is in bold, followed by "O. Ulmer" which is also in bold but with a decorative outline. The word "for" is smaller and in a regular font, positioned to the right of the name.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
HREY&ASSOCIATES ...
Christine M. Humphre CHUMPHREY@CHPALAW.CO ADMITTED IN FLORIDA
501 BRICKELL KEY DRIVE SUITE 104 MAMI. FLORIDA 33131 P: 305.372.2421 F: 305.372.7983
October 1, 2012
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SmartGuard® Night Guard® Original, SmartGuard® Night Guard Original and SmartGuard Elite™
Indications For Use:
OTC:
- Protection against bruxism or night time teeth grinding ♥
- Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding .
Rx:
- Protection of teeth grinding, bruxism, and jaw clenching. o
- Protection of restorations from injury due to bruxism or clenching. o
- Relief of bruxism related headaches and pains. .
- Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of . chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated o headaches and pains.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
AND/OR
| Over-The-Counter Use | X |
|---|---|
| ---------------------- | --- |
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mary S. Runner -5 Concurrence of CDRH, Office of Device Evaluation (ODE) 2013.03.14 1.1 :57:49 -04'00'
Division Sign-Off) )ivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number:
(Part 21 CFR 801 Subpart D)
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