(71 days)
The Doctor's NightGuard 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.
The Doctor's NightGuard is composed of a soft, formable clear upper material, made of ELVAX® resin, a copolymer of ethylene and vinyl acetate, and a hard occlusal base, which cushions the teeth. The base is composed of 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.
This 510(k) summary for the Doctor's® NightGuard™ explicitly states that no performance data is required to support the 510(k) notification. The device's substantial equivalence is primarily based on its similarity to legally marketed predicate devices, not on a new study demonstrating its efficacy or performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria and study design are not applicable in this case.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission states: "No performance data is required in support of this 510(k) notice." | Not applicable. No performance data was provided or required. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. No test set was used for a performance study. The substantial equivalence was based on technological characteristics and intended use in comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. No ground truth was established through expert review for a performance study.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted or reported.
6. Standalone (Algorithm Only) Performance Study:
- No. This device is a physical dental protector, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
- Not applicable. No ground truth was used for a performance study. The substantial equivalence argument relies on comparing the device's design, materials, and intended use to existing devices.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product and does not involve a training set as would be found in artificial intelligence or machine learning applications.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set for this type of device.
Summary of the Device's Substantial Equivalence Justification:
The Doctor's® NightGuard™ achieved substantial equivalence by demonstrating that it is:
- Physically the same as the predicate device, Dental Concepts' BruxGuard.
- Composed of similar materials (ELVAX® resin and Elvaloy® copolymer) with similar technological characteristics.
- Has a similar intended use (protection against bruxism) as the predicate devices, including the BruxGuard, Hollywood Products Mouth Peace, and GEM Scientific Products, Inc. Tension Reliever.
- Revised its labeling to be suitable for Over-The-Counter (OTC) use, aligning with the OTC status of some predicate devices.
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MAR 3 2006 510(k) SUMMARY
Dental Concepts The Doctor's® NightGuard™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson, LLP 555 13th Street, N.W. Washington, D.C. 20004
Howard M. Holstein Contact:
(202) 637-5600 Phone: (202) 637-5910 Facsimile:
Date Prepared: December 22, 2005
Name of Device and Name/Address of Sponsor
Doctor's® NightGuard™
Dental Concepts, LLC 650 From Road Paramus, NJ 07652
| Contact Person: | Michael Lesser, President |
|---|---|
| Phone: | (201) 225-2151 |
| Facsimile: | (201) 576-9780 |
Common or Usual Name
Dental Protector
Classification Name
Unclassified
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Predicate Devices
Dental Concepts BruxGuard Hollywood Products Mouth Peace GEM Scientific Products, Inc. Tension Reliever
Intended Use / Indications for Use
The Doctor's NightGuard 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.
Technological Characteristics
The Doctor's NightGuard is composed of a soft, formable clear upper material, made of ELVAX® resin, a copolymer of ethylene and vinyl acetate, and a hard occlusal base, which cushions the teeth. The base is composed of 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.
Performance Data
No performance data is required in support of this 510(k) notice.
Substantial Equivalence
The Doctor's NightGuard is as safe and effective as Dental Concepts' BruxGuard. The two devices are physically the same. The labeling for the Doctor's NightGuard has been revised to make it suitable for OTC use. Because the two devices are the same, the Doctor's NightGuard possesses the same technological characteristics and principles of operation and a similar intended use as the BruxGuard predicate device. The Doctor's NightGuard also has similar intended uses and indications as the Hollywood Products Mouth Peace and the GEM Scientific Products, Inc. Tension Reliever, which were sold over the counter, like the NightGuard. Thus, the Doctor's NightGuard is substantially equivalent.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a traditional symbol of medicine and healing.
MAR 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dental Concepts Limited Liability Corporation C/O Mr. Howard M. Holstein Hogan & Hartson Limited Liability Partnership 555 Thirteenth Street, NW Washington DC 20004
Re: K053580
Trade/Device Name: Doctor's Nightguard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: December 22, 2005 Received: December 22, 2005
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.
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Page 2 - Mr. Howard M. 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 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,
Sim Runoor
Sea-Chin Liu, Ph.D.
7 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
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Indications for Use Statement
K053580 510(k) Number (if known):__
Device Name: Doctor's® NightGuard™
Indications for Use:
The Doctor's NightGuard 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.
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over The - Counter Use X (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)
Susan Suarez
or dogs General Huspi Juntal Lovices
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