(88 days)
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.
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.
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.
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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'".
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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.
§ 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.”