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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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