(38 days)
Fabrication of full and partial dentures
VITRON® H is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication of complete or partial removable dentures and other removable dental appliances. VITRON® H is a pourable, heat cured material for the production of dentures according to the plugging-pressing procedure of flask polymerization.
This document is a 510(k) summary for VITRON® H, a denture base material. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of the requested sections regarding device performance and ground truth cannot be fully provided from the given text.
Here is the information that can be extracted or inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. The core of the submission relies on the "substantial equivalence" of VITRON® H to already marketed predicate devices with a long clinical history. The performance is implied to be equivalent to these predicate devices.
| Metric / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (VITRON® H) |
|---|---|---|
| Material composition | Similar monomer system to predicates | Uses common monomer system (methylmethacrylate) |
| Curing mechanism | Barbituric acid catalyzed system, similar to predicates | Uses barbituric acid catalyzed starting mechanism |
| Intended Use | Fabrication of complete or partial removable dentures and other removable dental appliances, same as predicates | Fabrication of full and partial dentures |
| Safety & Effectiveness | Comparable to predicates with long marketing history and clinical experience | Substantially equivalent to PALADON® 65, PALAPRESS® VARIO, and LIQCRYLIC® PRO DENTAL RESIN, all well-established as safe and effective. No biocompatibility studies deemed necessary due to long clinical history of similar technology. |
| Performance Data | Supports safety and effectiveness for intended use (presumably through physical and chemical property comparisons, though not detailed in this summary) | Performance data (not detailed in this summary) supports safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly detailed in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices with long marketing histories and clinical experience. This suggests the "test set" is more of a comparative analysis rather than a direct study on VITRON® H with a specific sample size. The provenance is inferred to be from general clinical history and market experience of the predicate devices.
- Sample Size for Test Set: Not specified.
- Data Provenance: The claim is based on the long marketing history and clinical experience of predicate devices (PALADON® 65, PALAPRESS® VARIO, LIQCRYLIC® PRO DENTAL RESIN). These predicates have been marketed in the United States since 1992 (PALAPRESS® VARIO) and in Europe/South America for over 25 years (SELECTA-PLUS® and TREVAPRESS®). This suggests historical and retrospective data from diverse regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. The ground truth for the safety and effectiveness of the predicate devices is established by their market longevity and clinical acceptance over many years. For VITRON® H, its substantial equivalence to these predicates negates the need for new expert ground truth establishment in this context.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a specific test set with human adjudication in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a denture base material, not an AI or imaging device that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an software/AI device.
7. The Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of VITRON® H is indirectly established through the long-term clinical history, market acceptance, and established safety and effectiveness of its predicate devices. The document states that the technology (methyl methacrylate based denture base materials cured by a barbituric acid based catalyst system) is over 30 years old and has a long clinical history.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.