(27 days)
Not Found
No
The device description and intended use describe a physical, adjustable mouthguard with a wear indicator. There is no mention of software, data processing, or any terms related to AI or ML.
Yes
The device is intended to reduce damage to the teeth and prevent noise associated with bruxing or grinding, which are therapeutic benefits addressing a medical condition (bruxism).
No
Explanation: The device is indicated for protection against bruxism and reducing damage to teeth, not for diagnosing a medical condition. It is a protective device.
No
The device description clearly outlines physical components (bite pads, buccal retaining strap) made of specific materials (Elvax, Elvaloy), indicating it is a hardware device, not software-only.
Based on the provided information, the DenTek Comfort Fit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- The DenTek Comfort Fit is a physical device intended for direct use in the mouth. Its purpose is to protect teeth from grinding, not to analyze biological samples.
The description clearly indicates it's a physical appliance worn in the mouth for mechanical protection.
N/A
Intended Use / Indications for Use
The Comfort Fit is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
Product codes
OBR
Device Description
The Comfort Fit consists of two bite pads and one buccal retaining strap. The bite pads consist entirely of Elvax, and the buccal retaining strap consists of Elvaloy. The bite pads move along the buccal strap to adjust to the individual user needs with the strap always contained within the wings of the bite pads. There are 4 positions of adjustability for each molar pad. There is a built in wear indicator, which helps the user determine when they need to replace their Comfort Fit.
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
Over-The-Counter Use
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DenTek's Comfort Fit
AUG 3 0 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
John Jansheski DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 (865) 983-2444 Facsimile:
OR
Howard Holstein, Esq. Hogan and Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington, DC, 20004 Phone: (202) 637-5813 Facsimile: (202) 637-5910
Date Prepared: July 27, 2007
Name of Device and Name/Address of Sponsor
DenTek's Comfort Fit NightGuard DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 Facsimile: (865) 983-2444
Common or Usual Name
Nightguard
Classification Name
Unclassified
Predicate Devices
DenTek Oral Care, Inc.'s NightGuard (K063483)
1
Power Product Inc.'s Splintek EZ-Splint (K022809)
Purpose of the Special 510(k) Notice
The Comfort Fit is a modification to the DenTek NightGuard.
Intended Use
The Comfort Fit is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
Technological Characteristics
The Comfort Fit consists of two bite pads and one buccal retaining strap. The bite pads consist entirely of Elvax, and the buccal retaining strap consists of Elvaloy. The bite pads move along the buccal strap to adjust to the individual user needs with the strap always contained within the wings of the bite pads. There are 4 positions of adjustability for each molar pad. There is a built in wear indicator, which helps the user determine when they need to replace their Comfort Fit.
Substantial Equivalence
The Comfort Fit has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate devices. Thus, the Comfort Fit 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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DenTek Oral Care, Incorporated C/O Mr. Howard M. Holstein, Esq. Regulatory Counsel Hogan & Hartson, L.L.P 555 13" Street NW Washington, DC 20004
AUG 3 0 2007
Re: K072147
Trade/Device Name: DenTek Comfort Fit NightGuard Regulation Number: Unclassified Regulation Name: Not Applicable Regulatory Class: Unclassified Product Code: OBR Dated: August 3, 2007 Received: August 3, 2007
Dear Mr. Holstein:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Holstein
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sudite y. Michie Oms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Konz147
Attachment 9
Indications for Use Statement
Device Name: DenTek Comfort Fit NightGuard
Indications for Use: The DenTek Comfort Fit is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Prescription Use (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Ruar
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072147
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