For over the counter temporary replacement of soft denture lining until a Dentist can be seen.
An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

Device Description

The subject device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand. The material contains no Methyl Methacrylate Monomer, no Phthalate Plasticizer, no Bisphenol A, no leachable alcohol and no Cadmium colors.

AI/ML Overview

This document is a 510(k) summary for the Majestic Drug Inc. Reline-It™ device. It outlines the regulatory process for an Over-The-Counter (OTC) denture reliner and asserts its substantial equivalence (SE) to already marketed predicate devices. However, it does not contain a study that would establish acceptance criteria for device performance in the manner typically seen for medical devices with diagnostic or treatment claims.

Here's why and what can be extracted from the provided text:

Lack of Performance Study and Acceptance Criteria:

The core of your request revolves around acceptance criteria and a study proving the device meets them. This type of detailed performance data (e.g., sensitivity, specificity, accuracy, or a specific metric with a defined threshold) is generally required for devices that perform a clinical function with measurable outcomes, such as diagnostic devices or treatment systems.

For an OTC denture reliner seeking 510(k) clearance, the primary focus is on demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The "Performance Data" section in the summary (Page 1) merely states: "Articles and supporting documents are included in sections 'Conformance to Voluntary Standards' and 'Clinical and Scientific Studies'". However, the provided text does not include these sections or details of any specific performance study, acceptance criteria, or their results.

The summary emphasizes chemical composition and safety (e.g., "no Methyl Methacrylate Monomer, no Phthalate Plasticizer, no Bisphenol A, no leachable alcohol and no Cadmium colors") and the method of application/removal, rather than a quantifiable performance metric for "relining a denture."

Based on the provided text, the following information is either not applicable or not present:

Table of acceptance criteria and reported device performance: Not present. The 510(k) summary does not define specific performance metrics or acceptance criteria for its effectiveness as a denture reliner in a quantifiable way.
Sample size used for the test set and the data provenance: Not applicable, as no performance test set is described.
Number of experts used to establish the ground truth and their qualifications: Not applicable, as no ground truth for performance is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for comparing human performance with and without AI assistance, which is not relevant to this device.
Standalone (algorithm only) performance: Not applicable. This device is a physical product, not an algorithm.
Type of ground truth used: Not applicable, as no performance study is detailed.
Sample size for the training set: Not applicable, as there's no machine learning model or "training set" for this device.
How the ground truth for the training set was established: Not applicable.

What the document does provide in relation to acceptance/equivalence:

The "acceptance criteria" in a 510(k) for such a device are intrinsically linked to demonstrating substantial equivalence to predicate devices. The "study" (or rather, the regulatory submission process) seeks to prove this equivalence.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):
- Same Intended Use: The device aims to be "An over the counter temporary Denture Reliner, intended to replace a worn denture lining." This aligns with OTC denture reliners.
- Similar Technological Characteristics: The device is described as "a monomer liquid and (2) a polymer powder which are mixed together prior to application... This results in a plastic resin paste..." and it highlights the absence of certain harmful chemicals (Methyl Methacrylate Monomer, Phthalate Plasticizer, Bisphenol A, leachable alcohol, Cadmium colors). This suggests its chemical composition and mechanism are similar to, or safer than, predicate devices.
- No New Questions of Safety or Effectiveness: The submission argues that its "chemistry, methods of application and intended use are essentially identical" to predicate devices, implying it poses no new safety or effectiveness concerns.
- Conformance to Guidance Documents: The submission explicitly states its purpose is to "follow the Food and Drug Administrations' Guidance document issued Aug 18, 1998 'OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits'".
The "Study" (i.e., the basis for clearance):
- The entire 510(k) submission itself serves as the "study" demonstrating the device meets the implicit acceptance criteria of substantial equivalence.
- Predicate Devices: The submission identifies three predicate devices:
  - DEN MAT CORP "DENTURE-TIGHT" K790589
  - LEE PHARMACEUTICALS "ACRYLINE 2" (510(k) unknown)
  - PERMA LABORATORIES PERMA SOFT II (510(k) unknown)
- Argument for Equivalence: The submitter states, "Majestic Drug Inc. maintains that the subject device is substantially equivalent to the predicate devices in that they all are similar in technology, function and intended use." It further elaborates, "The subject device is substantially equivalent (materials, technology) to the above listed devices."
- Data Provenance (for the basis of equivalence): The "data provenance" for the argument of equivalence relies on previously cleared devices (for which performance and safety would have been established at their time of clearance) and the general understanding of OTC denture reliners. The submission acknowledges that "technical data on formulation and a marketed sample was not available from present research efforts" for Den-Mat's product and that 510(k)s couldn't be found for the other predicates, necessitating reliance on the FDA's guidance document and the detailed formulation of the Reline-It™.

In summary, the provided document is a regulatory summary for a 510(k) submission focused on substantial equivalence for an OTC physical product. It does not contain a study with specified acceptance criteria and measured performance in the context of typical diagnostic or therapeutic medical devices.

Summary

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Majestic Drug Inc. Reline-Itm 510(k) Summary

K101771

Date Prepared [21CFR 807.92(a)(1)]

June 18, 2010

Submitter's Information [21CFR 807.92(a)(1)]

Sponsor:

SEP 2 0 2010

Mr. Larry Fishman President & CEO Majestic Drug Inc. 4996 Main St., Route 42 PO Box 490 S. Fallsburg, NY 12779 Telephone: 845-436-0011

The establishment registration number for Majestic Drug Inc. is 2411564

Contact Information:

Roger S. Mastrony Quality Systems/Regulatory Consulting Services 848-1/2 Derby Avenue Orange, CT. 06477 Telephone: 203-640-5047 Fax: 203-298-0438

Trade Name, Common Name, Classification [21 CFR 807.92(2)[2)]

Trade Name:

Reline-It™

Device common, usual or Classification Names

Device: Reliner, denture, over the counter

Regulation Description: OTC Denture Reliner

Class

Classification: Class II Product Code: EBP, 21 CFR 872.3560

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Majestic Drug Inc. Reline-It™ 510(k) Summary

The subject device is packaged with the following items:

Container of clear polymer powder ●
Container of liquid monomer .
Mixing/Application Spatula �
. Mixing Tray
Instructions for Use .

Intended Use [21 CFR 807.92(a)(5)]

The device has the following "Indications for Use":

For over the counter temporary replacement of soft denture lining until a Dentist can be seen. .

Technological Characteristics [21 CFR 807.92(a)(6)[

Majestic Drug Inc. maintains that the subject device is substantially equivalent to the predicate devices in that they all are similar in technology, function and intended use.

Labels, Labeling

Per section "Labels and Instruction For Use"

Performance Data [21 CFR 807.92(b)(1)]

Articles and supporting documents are included in sections "Conformance to Voluntary Standards" and "Clinical and Scientific Studies"

Predicate Devices [21 CFR 807.92(a)(3)(1)]

DEN MAT CORP "DENTURE-TIGHT" K790589 .
LEE PHARMACEUTICALS "ACRYLINE 2"( 510(k) unknown) .
PERMA LABORATORIES PERMA SOFT II. ( 510(k) unknown) ●

The subject device is substantially equivalent (materials, technology) to the above listed devices.

{2}------------------------------------------------

Majestic Drug Inc. Reline-It™ 510(k) Summary

Device Description [21 CFR 807.92(a)(4)]

The subject device is similar to the device that was cleared under premarket submission to DEN - MAT CORP K790589 DENTURE-TIGHT, LEE PHARMACEUTICALS "ACRYLINE 2" a currently available OTC denture reliner and PERMA LABORATORIES PERMA SOFT II which is also marketed on the internet as an OTC product.

Background:

The purpose of this submission is to follow the Food and Drug Administrations' Guidance document issued Aug 18, 1998 "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits, " along with verbal technical guidance from FDA technical contacts to present a successful representation of the subject device to obtain an OTC marketing clearance by the FDA.

There is some confusion on the present availability of technical information on 3 existing marketed devices; (1) Den-Mat's "Denture-Tight" K790589 obtained clearance, however technical data on formulation and a marketed sample was not available from present research efforts, and (2) Lee Pharmaceuticals "Acryline 2" is presently available on the internet, however a 5100k) could not be found for the device. (3) In addition, the FDA database did have one other device listed under product code EBP. The device name is "PERMA SOFT II, manufactured by PERMA LABORATORIES. This device is currently marketed on the internet, however a 510(k) could not be found. Given these circumstances, a recent telephone conversation with a technical contact at the FDA indicated that a successful clearance could be obtained by demonstrating conformance to the above referenced document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits", and by clearly stating all warnings and precautions in the instructions for use and labeling. Each of these devices along with the subject device, "Reline-It™" are soft, removable over the counter denture reliners. The chemistry, methods of application and intended use are essentially identical.

The information in this submission will clearly detail the formulation, safety and effectiveness data of the subject device without the benefit of having technical information of the devices listed above and all similar pre amendment devices currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or waves.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Majestic Drug Company, Inc. C/O Mr. Roger S. Mastrony Quality Systems/Regulary Consulting Services 848-1/2 Derby Avenue Orange, Connecticut 06477

SEP 2 0 2010

Re: K101771

Trade/Device Name: Reline-It Regulation Number: 21 CFR 872.3560 Regulation Name: OTC Denture Reliner Regulatory Class: II Product Code: EBP Dated: June 24, 2010 Received: June 24, 2010

Dear Mr. Mastrony:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mastrony

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Antions D. Mntr

Anthony D. Watson, B.S., M.S., M.B.A. 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" Statement

510(k) Number (if known):_

K101771

SEP 2 0 2010

Device Name: Reline-It ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The Device has the following "Indications for Use":

An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

Prescription Use (per 21 CFR 801.109)

Over-The Counter Use _ X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sina Rusone

(Optional Format 1-2-96)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K101271

్10(k) Number:

Majestic Reline-It/RSM

Regulation Number and Section

§ 872.3560 OTC denture reliner.

(a)
Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”