(131 days)
The Hyflex impression materials are intended to be injected directly into the mouth, depending on the technique and device and used to reproduce the structure of a patient's teeth and gums. provide models for study and for production of restorative prosthetic devices.
Hyflex Heavy and Mono are to be used as heavy-bodied materials for;
- One step impression technique (simultaneous technique) using single or dual viscosities.
- Two step impression technique using dual viscosities. -
- -Functional impressions.
Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for;
- Taking impression over fixed/removable restorations and implants -(i.e., transferring impression posts and bridge components)
- Functional impressions. -
- Fabricating crown and bridgework or inlays. -
- -Fabricating full or partial dentures.
- Reline impressions. -
- -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques.
- Transferring root posts when fabricating posts and cores indirectly. -
Hyflex Light is to be used as syringeable impression materials for;
- Two step putty-wash impression technique. -
- One step putty-wash impression technique. -
- -One step impression technique using a foil(plastic putty spacer).
- -Reline impressions.
- -Fabricating full or partial dentures
Hyflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Hyflex Impression Material family consists of three different viscosities( heavy, mono, light)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hyflex Impression Materials:
Please note that this document refers to a 510(k) premarket notification. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for de novo devices. Therefore, the "acceptance criteria" here primarily relate to meeting bench testing standards comparable to the predicate device, not necessarily pre-defined clinical outcome targets.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ISO 4823 standard and the comparative performance of the predicate device (Suflex Impression Materials K13357). The device performance is deemed acceptable if it passes the standard tests and exhibits comparable or superior properties to the predicate.
| Acceptance Criteria (Implicit from ISO 4823 & Predicate Performance) | Hyflex Impression Materials (Reported Performance) | Suflex Impression Materials K133527 (Predicate Performance) |
|---|---|---|
| Biocompatibility (Pass/Fail) | ||
| Cytotoxicity (ISO 10993-5) | Pass (All viscosities) | Pass (All viscosities) |
| Oral Irritation (ISO 10993-10) | Pass (All viscosities) | Pass (All viscosities) |
| Maximization and Sensitization (ISO 10993-10) | Pass (All viscosities) | Pass (All viscosities) |
| Physical Properties (Specific Values/Pass/Fail) | ||
| Component Colours (ISO 4823, 6.1) | Tested (Result not explicitly stated as value) | Not explicitly stated as value |
| Working Time (ISO 4823, 6.3) | Heavy: 2.022 min | |
| Mono: 2.612 min | ||
| Light: 2.850 min | Heavy: 2.02 min | |
| Mono: 1.53 min | ||
| Light: 2.25 min | ||
| Compatibility with Gypsum (ISO 4823, 6.4) | Pass (All viscosities) | Pass (All viscosities) |
| Consistency (ISO 4823, 6.4) | Heavy: 28.47mm | |
| Mono: 35.65mm | ||
| Light: 45.60mm | Heavy: 32.96mm | |
| Mono: 38.89mm | ||
| Light: 45.03mm | ||
| Detail Reproduction (ISO 4823, 6.4) | Pass (All viscosities) | Pass (All viscosities) |
| Linear Dimensional Change (ISO 4823, 6.4) | Heavy: 0.02% | |
| Mono: 0.02% | ||
| Light: 0.03% | Heavy: 0.04% | |
| Mono: 0.04% | ||
| Light: 0.04% | ||
| Elastic Recovery (ISO 4823, 6.4) | Heavy: 98.80% | |
| Mono: 98.60% | ||
| Light: 98.70% | Heavy: 98.41% | |
| Mono: 98.77% | ||
| Light: 98.33% | ||
| Strain-in-Compression (ISO 4823, 6.4) | Heavy: 2.30% | |
| Mono: 3.00% | ||
| Light: 2.30% | Heavy: 3.53% | |
| Mono: 4.35% | ||
| Light: 3.87% |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench testing" which implies laboratory-controlled tests on material samples, not a "test set" of human cases. The sample sizes for each specific test (e.g., consistency, working time) are not explicitly stated in this summary.
- Data Provenance: The document does not specify the country of origin for the data, nor whether it's retrospective or prospective, as it pertains to bench testing. The manufacturer is based in Busan, Republic of Korea, so it's reasonable to infer the testing was likely conducted or contracted there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device underwent bench testing and biocompatibility testing, not a clinical study involving experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. There was no human "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical studies are submitted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm device.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth was established by adherence to ISO 10993 standards and the resulting "Pass" or "Fail" criteria for specific biological responses (cytotoxicity, irritation, sensitization).
For physical properties, the ground truth was derived from the measurements obtained according to the specified ISO 4823 standard methods, and comparison against the predicate device's performance. The "ground truth" for these tests are the objective physical measurements themselves.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).