← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K053516 # MUCOHARD (K053516) _Parkell, Inc. · EBI · Jan 26, 2006 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K053516 ## Device Facts - **Applicant:** Parkell, Inc. - **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md) - **Decision Date:** Jan 26, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use A chemical (self) cure resin for use as a hard reline, repair, or rebase material for removable prostheses. ## Device Story MucoHard is a chemically cured, hard-setting resin material for dental prosthetics. It is delivered via a cartridge system and impression gun in a dental office setting. The process involves applying a primer liquid to the denture base, allowing it to dry, and then applying the resin, which adheres permanently to the primed surface. The material cures with minimal heat, allowing for intra-oral use. It is used by dental professionals to restore or repair removable acrylic prostheses, improving fit and function for the patient. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Chemically (self) cured resin material. Delivered via cartridge system and impression gun. Includes a primer liquid for adhesion to acrylic denture bases. Designed for intra-oral curing with minimal heat generation. ## Regulatory 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. ## Predicate Devices - Hard Reline - Ufi G Hard C - Rebase II - Secure Reline ## Related Devices - [K111177](/device/K111177.md) — JUELL HARD CURE · Juell Dental · Sep 12, 2011 - [K993827](/device/K993827.md) — UFI GEL HARD · Voco GmbH · Jan 20, 2000 - [K021586](/device/K021586.md) — SECURE RELINE/PICKUP MATERIAL · Imtec Corp. · Jun 14, 2002 - [K040881](/device/K040881.md) — METACRYL · Great Lakes Orthodontics, Ltd. · May 25, 2004 - [K011820](/device/K011820.md) — DENTORIUM CONVERTIBLE ACRYLIC · Nats Corp. · Sep 5, 2001 ## Submission Summary (Full Text) {0}------------------------------------------------ K053516 JAN 2 6 2006 3명 1992년 1992년 1992년 1992년 1982년 1992년 1992년 1992년 1982년 1992년 1992년 1982년 1972년 1972년 1972년 1972년 1972년 1972년 1972년 1972년 1972년 1972년 1972년 19 ## 510(k) SUMMARY | Submitter: | Parkell, Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: 631-249-1134<br>FAX: 631-249-1242 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, 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, hard<br>setting, resin material intended to be used for relining,<br>rebasing and/or repairing acrylic removable prostheses.<br>It is delivered from a cartridge system via an impression<br>gun found in the typical dental office. It is used in<br>conjunction with a primer liquid that is applied to a<br>denture base, allowed to dry and then applied to the<br>primed surface to which it permanently adheres. The<br>chemically polymerized material cures with minimal heat<br>so that it may be used intra-orally. The current device is<br>essentially similar to predicate devices and functions in a<br>similar manner and for the same uses as these, cited<br>elsewhere in this submission. | {1}------------------------------------------------ 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. {2}------------------------------------------------ ## 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 {3}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K053516](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K053516) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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