MUCOPREN SOFT RELINING SYSTEM by ROYDENT DENTAL PRODUCTS, INC.

The provided text is a 510(k) summary for the "Mucoderm™ soft reliner system" and primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study data typical of a clinical trial or performance study for a novel device.

Therefore, many of the requested information points (like specific acceptance criteria, detailed performance data, sample sizes for test/training sets, expert qualifications, and comparison studies) are not present in this document. This is common for 510(k) submissions where the device is considered substantially equivalent to already marketed devices, and thus extensive de novo studies may not be required to demonstrate safety and effectiveness.

However, based on the available information, here's what can be extracted:

Acceptance Criteria and Study for Mucoderm™ Soft Reliner System

The provided document describes a 510(k) submission for the Mucoderm™ soft reliner system, focusing on its substantial equivalence to predicate devices (K964040, K953589, K963736, and K954810). The primary "study" supporting its acceptance is the demonstration of substantial equivalence through comparison of intended use, technological characteristics, and material composition, along with biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated)	Reported Device Performance and Evidence
Intended Use: Long-term resilient lining material for removable dentures (reline, repair, rebase).	Meets: "These products have the same intended use, as a long-term resilient lining material for removable dentures, as the classified device and many cleared by the 510(k) process under K-964040 (Dentsply), K953589 (Tokuyama), K963736 (Sybron) and K954810 (Austenal)."
Technological Characteristics: Similar to predicate devices.	Meets: "The technological characteristics for this product are the same as those for the predicate devices and those currently on the market except for differences in methods of cure." (Acknowledges variation in cure methods across equivalent products).
Material Composition: Substantially equivalent to predicate devices.	Meets: "Descriptive information provided shows that the materials from which Mucopren™ is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market." (Note: Document uses both Mucoderm and Mucopren).
Biocompatibility: Safe for prolonged contact with mucosal membrane.	Meets: "Test data for biocompatibility of Mucopren was supplied in accordance with ODE General Program Memorandum #G95-1, using International Standard ISO 10993 for surface devices having prolonged contact with mucosal membrane. Less formal biocompatibility tests from Europe also were made. These data are supplied in Appendix III."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided document for any specific clinical or performance test set. The submission relies on comparison to predicate devices and general biocompatibility testing.
Data Provenance:
- Biocompatibility tests followed International Standard ISO 10993.
- "Less formal biocompatibility tests from Europe" were also made.
- The primary evidence is a comparison of characteristics to existing US-marketed predicate devices cleared via 510(k). The data underlying the safety and effectiveness of the predicate devices would be US-based, but not explicitly stated for this particular submission's "test set."
- Retrospective/Prospective: Not applicable to the primary substantial equivalence argument in this document. Biocompatibility testing would have been prospective for this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not specified. The document does not describe a clinical "test set" that required expert establishment of ground truth in the context of device performance metrics. The ground truth for biocompatibility would be established by laboratory testing against ISO standards.

4. Adjudication Method for the Test Set

Not applicable / Not specified. No explicit clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not mentioned or implied in the document, as the submission focuses on substantial equivalence rather than comparative effectiveness with human readers/users.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a dental relining material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is primarily the established safety and effectiveness of the predicate devices and compliance with biocompatibility standards (ISO 10993). There is no mention of "expert consensus," "pathology," or specific "outcomes data" in the context of a de novo clinical study for this device here.

8. The Sample Size for the Training Set

Not applicable / Not specified. This document describes a dental material, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this is not an AI/ML submission.

Summary

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XI. SAFE MEDICAL DEVICES ACT OF 1990 SUM OF SAFETY AND EFFECTIVENESS. Sept. 17, 1998. [Separate Pages]

510(1-15

I. * Submitter: Donald LeRoy, Roydent Dental Products, 1010 West Hamlin Rd., Rochester Hills. MI. 48309. Phone: 248-652-2500.

II. Classification Names and numbers: Denture relining, repairing, rebasing resin, 76EBI

III. Common/Usual Name: Relining, rebasing resin.

IV. Proprietary Names: Mucoderm™ soft reliner system

V. Establishment Registration Number: 2523439

VI. Classification: Denture relining, rebasing resins were classified by the Dental Devices Panel into Class II. They are described under CFR 872.3760.

VII. Substantial Equivalence: Roydent™ is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K964040, Trubyte Soft Reline System, Dentsply Int'l, K953589, Tokuyama Soft Relining, Tokutyama America; K963736, Soft Denture Rebasing Resin. Sybron Dental: K954810, Myerson IR Denture Base, Austenal, Inc.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, as a long-term resilient lining material for removable dentures, as the classified device and many cleared by the 510(k) process under K-964040 (Dentsply), K953589 (Tokuyama), K963736 (Sybron) and K954810 (Austenal).
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market except for differences in methods of cure. The methods of cure of those equivalent products also vary widely including light-cured, heat-cured, and timecured. Their composition also varies widely but has become fairly standard with acrylics or silicone polymeric substances.
Descriptive information provided shows that the materials from which Mucopren™ is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market.
The FDA "Decision-Making Process" chart was also used and appears in Appendix VI.
Test data for biocompatibility of Mucopren was supplied in accordance with ODE General Program Memorandum #G95-1, using International Standard ISO 10993 for surface devices having prolonged contact with mucosal membrane. Less formal biocompatibility tests from Europe also were made. These data are supplied in Appendix III.

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A specific guidance document is not available for relining, rebasing resin materials. However, we followed the general outline, and applicable parts of the recent guidance document, "Dental Impression Materials--Premarket Notification," issued 8/17/98. We believe we have complied fully with guidance documents and usual practices in preparing premarket notifications. If additional information or explanation is needed, please call me at 248-652-2500 or fax me at 248-652-2505. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, who is acting on my behalf, for a local response.

Sincerely yours

Dnzl Ry

Don LeRov President

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1998

Mr. Don Leroy President ROYDENT Dental Products 1010 West Hamlin Road Rochester Hills, Michigan 48309

K983357 Re : Mucopren™ Soft Relining System Trade Name: Requlatory Class: II Product Code: EBI September 23, 1998 Dated: September 24, 1998 Received:

Dear Mr. Leroy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Mr. Leroy

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K9833S7

VIII.1 Indications for Use: [Separate Page]

510(k) Number: NA

Device Name: Mucopren™ soft liner system

Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use_V (Per 21 CFR 801.109)

Over-The-Counter Use__
(Optional Format 1-2-96)

Susan Puoser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 19882277

Regulation Number and Section

§ 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.