(27 days)
Not Found
No
The device description focuses on the physical design and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is intended to protect against bruxism and reduce associated damage and noise, but it does not treat or cure a disease or condition in a therapeutic manner. It is a protective mechanical barrier.
No
Explanation: The device is indicated for protection against bruxism and teeth grinding by reducing damage and noise, which are preventative or protective functions, not diagnostic ones. It helps manage a condition rather than identify or diagnose it.
No
The device description explicitly states the device is made entirely of ELVAX, a thermoplastic material, and describes physical components like bite pads and a buccal retention strap. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism and teeth grinding, and to reduce associated damage and noise. This is a physical, mechanical function within the mouth.
- Device Description: The device is a physical dental guard made of thermoplastic material. It works by providing a barrier and cushioning between the teeth.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample (blood, urine, tissue, etc.), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental guard does not perform any such function.
N/A
Intended Use / Indications for Use
DenTek's New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
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.
Not Found
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
510(k) SUMMARY
JAN 1 0 - 2013
DenTek Oral Care Inc.'s -New-Comfort-Fit®-Dental-Guard=
Submitted in accordance with 21 CFR 807.92
Submitter's Name, Address, Telephone/Fax Number, Contact Person and Date Prepared:
DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 Facsimile: (865) 983-2444
Contact: Linda Giles Date Prepared: December XX, 2012
Name of Device: New Comfort-Fit® Dental Guard
Common or Usual Name: Dental Guard
Classification Name: Mouthguard, Over-the-Counter
Classification Product Code: OBR
Classification: Unclassified
Predicate Devices:
DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard (K081669).
Sleepright® Dura-Comfort® Dental Guard, formerly known as Sleepright® Advance, from Splintek - Power Products, Inc. (K071404).
Purpose of the Special 510(k) notice:
The New Comfort-Fit® Dental Guard is a modification to DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard (K081669).
1
Intended Use:
DenTek's New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
Technological Characteristics:
The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.
Substantial Equivalence:
DenTek's New Comfort-Fit® Dental Guard has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Improved Comfort-Fit NightGuard and Splintek's Sleepright® Dura-Comfort® Dental Guard. The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the New Comfort-Fit® Dental Guard is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
Ms. Linda Giles Regulatory Specialist DenTek Oral Care, Incorporated 307 Excellence Way MARYVILLE TN 37801
Re: K123849
Trade/Device Name: New Comfort-Fit® Dental Guard Regulation Number: Unclassified Regulation Name: Mouthguard, Over-The-Counter Regulatory Class: Unclassified Product Code: OBR Dated: December 13, 2012 Received: December 14, 2012
Dear Ms. Giles:
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.
3
Page 2 - Ms. Giles
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 53.1-542 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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
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
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Indications for Use Statement
510(k) Number (if known):
Device Name: New Comfort-Fit® Dental Guard
Indications for Use: KN3849
The New Comfort-Fit® Dental Guard is indicated for use for protection against The New Comilori-Tito Demail Guard It is intended to reduce damage to the teeth bruxism of high of high associated with bruxing or grinding.
Prescription Use (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use
(Per 21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
12013.01.02 Susan Runner DDS, MA 07:01:22 -05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division Cantrol Qental Devices Division of Anesthesionegy. -
K123849 510(k) Number:_