(27 days)
Not Found
No
The summary describes a physical, adjustable nightguard made of thermoplastic material. There is no mention of software, algorithms, or any technology that would suggest AI or ML is involved.
Yes
The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding, indicating a therapeutic purpose to protect the user from a medical condition (bruxism).
No
Explanation: The device is intended to protect against bruxism and teeth grinding, and to reduce damage and noise associated with it. It does not perform any diagnostic function.
No
The device description explicitly states it is made of a thermoplastic material and consists of physical components (bite pads, buccal retention strap), indicating it is a physical medical device, not software-only.
Based on the provided information, the DenTek Improved Comfort-Fit NightGuard is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DenTek Improved Comfort-Fit NightGuard is a physical device worn in the mouth to protect teeth from grinding. It does not involve testing biological samples.
- Intended Use: The intended use is for physical protection and noise reduction related to bruxism, not for diagnosing or detecting a condition through in vitro analysis.
Therefore, this device falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DenTek's Improved Comfort-Fit NightGuard 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.
Product codes
OBR
Device Description
The Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
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
JUL 1 0 2008
DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Howard M. Holstein, Esq. Hogan & Hartson LLP 555 13th Street NW Washington, DC 20004
(202) 637-5813 Phone: Facsimile: (202) 637-5910
June 13, 2008 Date Prepared:
Name of Device and Name/Address of Sponsor
Improved 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
Mouthguard, Over-the-Counter
Classification Product Code
OBR
Predicate Devices
DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)
1
Purpose of the Special 510(k) notice.
The Improved Comfort-Fit NightGuard is a modification to DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147).
Intended Use
DenTek's Improved Comfort-Fit NightGuard 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.
Technological Characteristics
The Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.
Substantial Equivalence
DenTek's Improved Comfort-Fit has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Comfort Fit. The minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness. Thus, the Improved Comfort-Fit is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
JUL 10 2008
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 LLP 555 Thirteenth Street, NW Washington, DC 20004
Rc: K081669
Trade/Device Name: Improved Comfort-Fit NightGuard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 13, 2008 Received: June 13, 2008
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 your 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 Parl 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
A. Samuel S. Ford, m.D. Hor
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
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Improved Comfort-Fit NightGuard
Indications for Use:
The DenTek Improved Comfort-Fit NightGuard 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)
Robert S. Betz MS/for Dr. Susan Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08/669