(41 days)
A chemical (self) cure resin for use as a hard reline, repair, or rebase material for removable prostheses.
This device is described as a chemically cured, hard setting, resin material intended to be used for relining, rebasing and/or repairing acrylic removable prostheses. It is delivered from a cartridge system via an impression gun found in the typical dental office. It is used in conjunction with a primer liquid that is applied to a denture base, allowed to dry and then applied to the primed surface to which it permanently adheres. The chemically polymerized material cures with minimal heat so that it may be used intra-orally. The current device is essentially similar to predicate devices and functions in a similar manner and for the same uses as these, cited elsewhere in this submission.
This 510(k) premarket notification (K053516) for MucoHard, a hard denture reline resin, does not include information about acceptance criteria or a study proving that a device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria. It provides:
- Submitter and Contact Information: Parkell, Inc. and Nelson J. Gendusa, DDS.
- Submission Date, Trade Name, Common Name, Classification Name: MucoHard, Hard Denture Reline Resin, Resin, Denture, Relining, Repairing, Rebasing.
- Equivalence: Lists predicate devices (Hard Reline, Ufi G Hard C, Rebase II, Secure Reline).
- Description/Intended Use: Describes the device as a chemically cured, hard-setting resin material for relining, rebasing, and/or repairing acrylic removable prostheses, delivered via an impression gun with a primer liquid. It emphasizes the minimal heat curing for intra-oral use and its similarity to predicate devices.
- FDA Communication: The letter from the FDA confirms review of the 510(k) and a determination of substantial equivalence to legally marketed predicate devices, allowing the device to proceed to market. It outlines compliance requirements for general controls, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Indications for Use: States that MucoHard is a chemical (self) cure resin for use as a hard reline, repair, or rebase material for removable prostheses. It is for prescription use.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided document.
The document is a 510(k) premarket notification, which primarily aims to demonstrate substantial equivalence to existing legally marketed devices, rather than detailing the results of performance studies against specific acceptance criteria. Typically, such studies would be conducted and their results summarized with acceptance criteria if a new clinical indication or significant new technology was being introduced, or if performance data was required to establish equivalence where other factors were insufficient. This submission appears to rely on material characteristics and intended use equivalence to predicates.
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JAN 2 6 2006
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510(k) SUMMARY
| Submitter: | Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: 631-249-1134FAX: 631-249-1242 |
|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 |
| Submission Date: | 13 December 2005 |
| Trade Name: | MucoHard |
| Common Name: | Hard Denture Reline Resin |
| Classification Name: | Resin, Denture, Relining, Repairing, Rebasing |
| Equivalence: | Hard Reline, Ufi G Hard C, Rebase II, Secure Reline |
| Description/Intended Use: | This device is described as a chemically cured, hardsetting, resin material intended to be used for relining,rebasing and/or repairing acrylic removable prostheses.It is delivered from a cartridge system via an impressiongun found in the typical dental office. It is used inconjunction with a primer liquid that is applied to adenture base, allowed to dry and then applied to theprimed surface to which it permanently adheres. Thechemically polymerized material cures with minimal heatso that it may be used intra-orally. The current device isessentially similar to predicate devices and functions in asimilar manner and for the same uses as these, citedelsewhere in this submission. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wings and a wavy line representing its body. 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
JAN 2 6 2006
Nelson J. Gendusa, DDS Director of Research Parkell. Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735
Re: K053516
Trade/Device Name: MucoHard Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 13, 2005 Received: December 16, 2005
Dear Dr. Gendusa:
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 cither 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 Fedcral Regulations, Title 21, Parts 800 to 898. In addition, I-DA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Nelson J. Gendusa, DDS
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" (21 CFR 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 vours,
Sepute y. Mickin Oms
Chiu S. Lin, PhD 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): K053516
Device Name:MucoHard Indications for Use:
A chemical (self) cure resin for use as a hard reline, repair, or rebase material for removable prostheses.
Prescription Use __ × (21 CFR Part 801 Subpart D) AND/OR ..
Over-The-Counter Use (21 CFR Part 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 Ramsey
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Laboratory, General Hospital
Control, Dental Devices
Y053316
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.