(107 days)
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Glidewell™ 3DP Denture Base Resin, is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Glidewell™ 3DP Denture Base Resin, is a light-cured methacrylic material with photo initiators that form a polymer during 3D printing. Glidewell™ 3DP Denture Base Resin is printed using digital light processing (DLP). The DLP printer and resin are optimized to each other in order to achieve complete and precise printed parts. The light source provided by the DLP printer (405nm wavelength), and the post-curing light box polymerize the resin which forms a hardened denture base. Once cured, Glidewell™ 3DP Denture Base Resin has the mechanical property that meets the performance criteria for Type 4: Light-activated materials as defined in the FDA-recognized consensus standard ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers, including flexural strength, flexural modulus, water sorption and water solubility.
The subject device, Glidewell™ 3DP Denture Base Resin, has the same formulation and manufacturing process as the predicate device, Glidewell™ 3DP Denture Base Resin (K213765), which contains silver sodium hydrogen zirconium phosphate. In vitro studies on the subject device, Glidewell™ 3DP Denture Base Resin, demonstrated a reduction in the following microorganisms: Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA (Methicillin Resistant Staphylococcus aureus), VRE (Vancomycin Resistant Enterococcus).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, presented in the requested format.
It's important to note that this document is a 510(k) Summary, which is a regulatory submission for medical devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results. Therefore, some information typically found in a full clinical study report (like detailed sample sizes for training sets or expert qualifications for ground truth) may not be explicitly stated for components not directly studied in this submission. The "study" described herein refers primarily to the in vitro antimicrobial testing.
Acceptance Criteria and Device Performance
Glidewell™ 3DP Denture Base Resin is a Class II device (Product Code EBI, Regulation Number 21 CFR 872.3760). The primary focus of the additional testing in this 510(k) submission (K241493) seems to be the antimicrobial properties of the resin, as its physical properties are stated to be identical to the predicate device (K213765).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Metric | Acceptance Criteria (Target/Threshold) | Reported Device Performance (Result) | Study Type/Standard |
|---|---|---|---|
| Physical Properties | |||
| Flexural Strength | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Flexural Modulus | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Water Sorption | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Water Solubility | Meets ISO 20795-1:2013 for Type 4 | Meets standard (same as predicate) | ISO 20795-1:2013 |
| Antimicrobial Properties (In Vitro) | |||
| Viable Count Reduction - Short-term | >99.9% reduction compared to control | >99.9% reduction for all 10 tested microorganisms (Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA, VRE) | ASTM E2180-07 |
| Viable Count Reduction - Long-term (Accelerated aging to 3 years) | >99.9% reduction compared to control | >99.9% reduction for S. mutans and C. albicans | ASTM E2180-07 & ASTM F1980-16 (modified) |
| Viable Count Reduction - Long-term (Real-time aging up to 6 months) | Significantly higher levels compared to control | Significant reduction for S. mutans and C. albicans | ASTM E2180-07 |
| Biofilm Formation/Growth Reduction | >90% reduction for S. mutans; >70% reduction for C. albicans | Achieved (>90% for S. mutans, >70% for C. albicans) | ASTM E2647-13 (modified) |
| Biocompatibility | Meets applicable endpoints | Biocompatible (per ISO 10993-1:2018 and ISO 7405:2018) | ISO 10993-1:2018, ISO 7405:2018 |
| Printer Compatibility | Printing accuracy & orientation validated for additional model | Asiga PRO 4K validated | Internal Validation |
2. Sample Sizes Used for the Test Set and Data Provenance
- Antimicrobial Tests (Test Set): The specific number of samples (replicates) used for each microorganism in the in vitro tests (ASTM E2180-07 and ASTM E2647-13) is not explicitly stated in this summary. These are typically material tests on prepared resin samples, not patient-derived data.
- Physical Properties: Not explicitly stated as the data for the subject device is leveraged from the predicate device (K213765), implying prior testing was performed for the predicate.
- Data Provenance: The studies are in vitro laboratory tests conducted by the manufacturer or their contracted labs. The provenance is internal to the manufacturer (Prismatik Dentalcraft, Inc.) and is retrospective as it supports a 510(k) submission. No country of origin for data generation is specified beyond the company's location in Irvine, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For these in vitro material and microbiology tests, "ground truth" is established by the standardized methods themselves (e.g., cell counts, optical density measurements, mechanical property testing according to ISO standards). This is not equivalent to establishing ground truth for AI algorithms based on expert interpretation of medical images. The tests measure objective physical and biological properties.
4. Adjudication Method for the Test Set
- Not Applicable. As these are in vitro laboratory tests measuring objective properties, an adjudication method among experts (like 2+1 or 3+1 for image reviews) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a denture base resin, not an AI software intended to assist human readers (e.g., radiologists). Therefore, an MRMC comparative effectiveness study is not relevant to this submission. The summary explicitly states: "Clinical studies have not been conducted to demonstrate that the presence of silver sodium hydrogen zirconium phosphate in Glidewell™ 3DP Denture Base Resin results in improved clinical outcomes."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a material (resin) device, not an algorithm.
7. The Type of Ground Truth Used
- For Antimicrobial Tests: Ground truth is established by quantitative microbial culture methods (viable plate counts) as per ASTM E2180-07 and ASTM E2647-13. The "control samples of regular denture without antimicrobial agent" serve as the baseline for comparison.
- For Physical Properties: Ground truth is established by standardized mechanical testing procedures as per ISO 20795-1:2013.
- For Biocompatibility: Ground truth is established by standardized biological evaluation tests per ISO 10993-1:2018 and ISO 7405:2018.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device because it is a physical material, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm.
§ 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.