K Number
K053516
Device Name
MUCOHARD
Manufacturer
Date Cleared
2006-01-26

(41 days)

Product Code
Regulation Number
872.3760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A chemical (self) cure resin for use as a hard reline, repair, or rebase material for removable prostheses.
Device Description
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.
More Information

Hard Reline, Ufi G Hard C, Rebase II, Secure Reline

Not Found

No
The device description focuses on the chemical composition and physical properties of a resin material, with no mention of AI or ML.

No.
The device is a material for repairing or rebasing prostheses, which are external devices, and does not directly provide therapy for a disease or condition within the body.

No

This device is a material used for relining, rebasing, and repairing dental prostheses, not for diagnosing conditions or diseases.

No

The device description clearly states it is a "chemically cured, hard setting, resin material" delivered from a "cartridge system via an impression gun," indicating it is a physical material and delivery system, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "a hard reline, repair, or rebase material for removable prostheses." This describes a material used to modify or repair a dental device, not to perform a diagnostic test on a biological sample.
  • Device Description: The description details a "chemically cured, hard setting, resin material" applied to a denture base. This is a material used in a dental procedure, not a test performed on a sample from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

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.

Product codes

EBI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental office

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Hard Reline, Ufi G Hard C, Rebase II, Secure Reline

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

K053516

JAN 2 6 2006

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19

510(k) SUMMARY

| Submitter: | Parkell, Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 631-249-1134
FAX: 631-249-1242 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
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
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. |

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