(27 days)
The 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.
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.
The provided text is a 510(k) Summary for a dental guard, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.
This 510(k) submission is for a "Special 510(k)," indicating minor modifications to an already cleared device. The key argument is that "The minor modifications made to the device do not raise any new questions of safety or effectiveness." This type of submission generally relies on comparing technological characteristics and intended use to a predicate device, rather than new clinical performance data.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or report performance data against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, not meeting specific performance benchmarks in a study.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. No clinical test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No test set requiring expert ground truth is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a physical dental guard, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement metrics are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a physical dental guard, not an algorithm. Standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No ground truth data is discussed. The device's safety and effectiveness are established by demonstrating similarity to predicate devices.
8. The sample size for the training set:
- Cannot be provided. No training set for an algorithm is mentioned as this is a physical device.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set is mentioned.
Summary of Device Information Available:
- Device Name: New Comfort-Fit® Dental Guard
- Intended Use: Protection against bruxism or nighttime teeth grinding; intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
- Technological Characteristics: Posterior-only occlusion dental guard, two bite pads connected by a buccal retention strap, made of ELVAX (thermoplastic material), adjustable (5 positions), with lingual wall bumpers and an upper vertical bite pad wall for enhanced retention.
- Predicate Devices:
- Basis for Clearance: Substantial equivalence to predicate devices, arguing that minor modifications do not raise new questions of safety or effectiveness.
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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).
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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.
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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.
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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:_
N/A