(98 days)
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
The gumEase® dental mouth piece is manufactured from biocompatible plastic tubing that is filled with a NaCl solution.
The provided text describes a 510(k) submission for the "gumEase® dental mouthpiece." This submission focuses on establishing substantial equivalence to predicate devices based on safety and effectiveness, rather than reporting on a clinical study with acceptance criteria and performance metrics for a novel diagnostic or treatment device.
Therefore, the requested information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
The document states that substantial equivalence was established by the "principle of similarity of the Intended Use, Biocompatibility operation, device design and Simmanty of the predicate devices." It also mentions "Biocompatibility testing was performed in accordance with the ISO 1993 guidelines and all test results confirmed the device is biocompatible."
Essentially, this is a regulatory clearance for a low-risk device based on its similarity to existing cleared devices, not a study evaluating and quantifying its performance against specific clinical efficacy or diagnostic accuracy criteria.
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BioMeDevice Ltd. 24931 Nellie Gail Rd. Laguna Hills, CA 92653 Tel. 949-362-9407 Fax: 949-362-9407
NOV - 5 2007
510K SUMMARY
mis summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510K number is: 1. Submitter's Identification:
BioMeDevice Ltd. 24931 Nielie Gail Laguna Hills, California 92653 Telephone: 949-362-9407 Facsimile: 949-362-
Contact Person: Brice Yoder, Office of the Chairman
Date of Summary: 7-27-07
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- Device Name: gumEase® dental mouthpiece
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- Classification Name: Not Classified
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- Predicate Device:
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Intended Use: The gumEase® dental mouth piece provides temporary relief from
the states of the first for and ental work, broce pain, denture irritation, post Intended Use: The gumEase "dental mouth pless provides of the many of the promotion, post surgical pain, or minor oral trauma.
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Device Description/ Comparison: The gumEase® dental mouth piece is Device Description/ Companson. The gamelaso that is filled with a NaCl solution.
manufactured from biocompatible plastic tubing that is filled with a NaCl solution. manufactured from blocompatible plasticate devices was established by principle of
Substantial equivalent to the predicate devices was established by principlity Substantial equivalent to the predication of indication of use. Biocompatibility operation, device design and Simmanty of the ISO 1993 guidelines and all test
testing was performed in accordance with the ISO 1993 guidelines and all test testing was performed in accordance with the 100 100 games is biocompatible.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2007
Dr. Brice I.. Yoder Chief Executive Officer BioMeDevice, Limited 24931 Nellie Gail Road Laguna Hills, California 92653
Re: K072082
Trade/Device Name: GumEase® Dental Mouth Piece Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: October 25, 2007 Received: October 26, 2007
Dear Dr. Yoder:
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. Yoder
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.
Nel R.C. Ayle
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
510(k) Number (if known):
Device Name: gumEase® dental mouth piece
Indications For Use:
ndications For Use:
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
rescription Use Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OND)
Susan Penrose
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Page 1 of
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.