(231 days)
The D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430~490nm waveband of visible light.
D1 by DXM Co., Ltd. is classified as an Ultraviolet Activator for polymerization (21 CFR 872.6070) because it is a device intended for the photopolymerization light cured dental materials. The D1-Cordless is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490nm waveband of spectrum with a power density of 3,000mW/cm² (11-8mm light-guide). These power densities are sufficient for the product intended uses, namely, Photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials, restorative composite materials, and orthodontic brackets and orthodontic bonding and sealing materials.
D1 has two operating modes: Plasma Emulation/ Ortho mode: 3000 mW/cm² and High Power mode: 1500 mW/cm2.
Exposure timing intervals for Plasma Emulation mode is 1, 2, 3 seconds, Ortho: approximately 3 seconds on, 1 second off for 16 cycles and High Power mode: 5, 10, 20, 40 seconds.
The D1 Curing light is cordless and is powered by a rechargeable Lithium-lon battery which is charged by a Battery Charger Stand supplied with a certified AC/DC Adapter.
The provided text describes the 510(k) submission for the D1 LED Curing Light, which is a device intended to polymerize resinous dental materials. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes non-clinical bench tests performed to verify specific technical aspects of the device against established standards and expected performance for similar devices.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Verification of Spectral Irradiance Output | Confirmed as part of testing |
| Verification/Validation of Irradiance Intensity | Confirmed as part of testing (specifically, 3,000mW/cm² for Plasma Emulation/Ortho mode and 1,500mW/cm² for High Power mode) |
| Depth of Cure | Confirmed as part of testing |
| Verification of Case Temperature Rise | Confirmed as part of testing |
| Compliance with IEC 60601-1: 1988 +A1 1991, +A2 1995 | Met through testing |
| Compliance with ANSI/AAMI/IEC 60601-1-2: 2007 | Met through testing |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Met through testing |
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Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data for performance evaluation in the way one would for a diagnostic or AI algorithm. Instead, it refers to non-clinical bench tests. For these bench tests, sample sizes are not explicitly stated. The data provenance is from non-clinical bench testing conducted in a lab setting, likely by DXM Co., Ltd. or a contracted testing facility. No country of origin for a clinical data set is applicable as no clinical studies were performed.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth in the context of expert consensus on clinical cases was established, as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications derived from the predicate devices and relevant standards.
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Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication was used.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a dental curing light device.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The D1 LED Curing Light is a physical device, not an algorithm. The "standalone" performance refers to the device's technical specifications and functionality, which were evaluated through bench testing.
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Type of Ground Truth Used:
The "ground truth" for this submission is based on engineering specifications, established international and national standards (e.g., IEC 60601-1, ANSI/AAMI/IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the performance characteristics of predicate devices. For example, the irradiance intensity of 3,000mW/cm² (Plasma Emulation/Ortho mode) and 1,500mW/cm² (High Power mode) would be a performance characteristic verified against the device's design specifications, which are implicitly derived from the requirements for effectively polymerizing dental materials and the performance of predicate devices.
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Sample Size for the Training Set:
Not applicable. There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.
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How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.