(34 days)
Not Found
No
The device description focuses on the physical materials and molding process, and there is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes
The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding, which are therapeutic effects addressing a medical condition (bruxism).
No
Explanation: The device is indicated for protection against bruxism and teeth grinding, and to reduce damage and noise associated with these conditions. It is a protective and preventative device, not one used to diagnose a medical condition.
No
The device description clearly states it is composed of physical materials (ELVAX® resin and ELVALOY®) that are molded to fit the user's teeth, indicating it is a physical medical device, not software.
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 (teeth grinding) and reducing damage to teeth. This is a mechanical function related to the physical structure of the mouth and teeth.
- Device Description: The device is a physical mouthguard made of specific materials designed to be molded to the teeth and provide a barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a disease or condition based on such analysis. IVDs are used to diagnose, monitor, or screen for diseases or conditions in vitro (outside the body).
The device is a physical appliance for managing a condition, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Doctor's® NightGuard™ Advanced Comfort™ 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 grinding.
Product codes
OBR
Device Description
The Doctor's® NightGuard™ Advanced Comfort™ is composed of a soft, formable clear upper material, made of ELVAX® resin (a copolymer of ethylene and viny) acetate) and ELVALOY® (a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate). When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.
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)
No performance data is required in support of this Special 510(k) notice.
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
K 073220
Special 510(k) SUMMARY
DEC 1 9 2007
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| 1. Submitter's Name: | Dental Concepts, LLC |
|---|---|
| Address: | 90 North Broadway, Irvington, New York 10533 |
| Telephone Number. | (914) 524-6842 |
| Contact Person: | Karen A. Costa-Strachan, Ph.D. |
| Date Prepared: | November 14, 2007 |
-
- Device Name: Proprietary Name: The Doctor's® NightGuard™ Advanced Comfort™ Common or Usual Name: Dental Protector (Over-the-Counter) Classification Name: Unclassified Product Code: OBR
-
- Devices to Which Substantial Equivalence is Claimed:
Primary Predicate Device: Dental Concepts The Doctor's® NightGuard™ Classic™ (K053580)
Secondary Predicate Device: Dental Concepts BruxGuard™ (K024261)
4. Device Description and Technological Characteristics:
The Doctor's® NightGuard™ Advanced Comfort™ is composed of a soft, formable clear upper material, made of ELVAX® resin (a copolymer of ethylene and viny) acetate) and ELVALOY® (a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate). When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.
5. Intended Use Statement:
The Doctor's® NightGuard™ Advanced Comfort™ 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 grinding.
6. Performance Data:
No performance data is required in support of this Special 510(k) notice.
7. Substantial Equivalence:
Doctor's® NightGuard™ Advanced Comfort™ possesses the same The technological characteristics, principles of operation and intended use as the predicate devices (currently marketed The Doctor's® NightGuard™ Classic™ and BruxGuard™) . Therefore, The Doctor's® NightGuard™ Advanced Comfort™ is substantially equivalent to both predicate devices.
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Image /page/1/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is black and the background is white.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter.
DEC 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karen Costa-Strachan, Ph.D. Director Regulatory Affairs Prestige Brands, Incorporated 90 N Broadway Irvington, New York 10533
Re: K073220
Trade/Device Name: The Doctor's® NightGuard™ Advanced Comfort™ Regulation Number: None Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OBR Dated: November 14, 2007 Received: November 23, 2007
Dear Dr. Costa-Strachan:
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.
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Page 2 -- Dr. Costa-Strachan
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
3
K073220
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INDICATIONS FOR USE STATEMENT
to prevent the noise associated with bruxing or grinding.
| Applicant: | Dental Concepts, LLC |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | The Doctor's® NightGuard™ Advanced Comfort™ |
| Indications for Use: | The Doctor's® NightGuard™ Advanced Comfort™ is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and |
Sue Cumpe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ 073200
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-the-Counter Use or (Per 21 CFR 801.109)
PROPRIETARY DATA: This document and information on be reproduced, used or disclosed without written permission of Dental Concepts, LLC.
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