(112 days)
Suflex Putty is to be used as panasil putty material for;
- Two step putty impression technique
- One step putty impression technique
- Two step putty impression technique using a foil(plastic putty spacer) .
- One step putty impression technique for forming functional peripheries. -
Suflex Heavy is to be used a s panasil tray material for;
- One step impression technique using sinte or dual viscosities. ।
- Two step impression technique using dual viscosities ।
- Functional impressions. -
Suflex Mono is to be used as panasil monophase material for;
- Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
- -Fuctional impresssions.
- Fabricating crown and bridgework or inlays. .
- Fabricating full or partical dentures. .
- Reline impressions. י
- Use in the simultaneous mixing technique as well as the putty -
- Trnasferring root posts when fabricating posts and cores indirectly. .
Suflex Light is to be used as panaasil contact material for;
- Two step putty impressiontechnique. ।
- One step putty impression technique. ।
- One step impression technique using a foil(plastic putty spacer) l
- One step impression technique(simultaneous technique)using dual viscosities. .
- -Reline impressions.
- Fabricating full or partial dentures. -
Suflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Suflex Impression Material family consists of four different viscosities(putty, heavy, mono, light), available in an assortment of delivery systems: traditional 1:1 50ml, automix cartridge, 5:1 362ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Suflex Impression Materials":
Important Note: The provided document is a 510(k) summary for a medical device (dental impression material). These summaries typically don't contain detailed statistical analyses, sample sizes for specific performance metrics, or information about complex AI/ML study designs (like MRMC studies) because the device itself is a material, not a software algorithm. The focus of this submission is on demonstrating substantial equivalence to predicate devices through material properties and biocompatibility.
Acceptance Criteria and Reported Device Performance for Suflex Impression Materials
This submission describes Suflex Impression Materials, which are addition-curing, elastomeric materials for dental impressions. The acceptance criteria and performance are established through bench testing of physical properties and biocompatibility, primarily by demonstrating equivalence to predicate devices or compliance with ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric (Reference) | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5) | Comparable to other materials on the market | Biological safety assured |
| Sensitization (ISO 10993-10) | Comparable to other materials on the market | Biological safety assured |
| Mucosa Irritation (ISO 10993-10) | Comparable to other materials on the market | Biological safety assured |
| Chemical Analysis | Biocompatibility data comparable to other materials on the market | |
| Mechanical Properties (Bench Testing) | Evaluation in comparison to already marketed products | |
| Component colors (ISO 4823, 6.1) | Results indicate adequate consistency | Compared to leading impression materials |
| Working time (ISO 4823, 6.3) | Results indicate adequate consistency | Compared to leading impression materials |
| Compatibility with gypsum (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
| Consistency (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
| Detail reproduction (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
| Linear dimensional change (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
| Elastic recovery (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
| Strain-in-compression (ISO 4823, 6.4) | Results indicate adequate consistency | Compared to leading impression materials |
Summary of Device Performance: The Suflex Impression Materials demonstrated adequate consistency in their mechanical properties when compared to leading impression materials already on the market, based on ISO 4823 test methods. Furthermore, biocompatibility testing (cytotoxicity, sensitization, mucosa irritation, and chemical analysis) showed comparable data to other marketed materials, assuring biological safety in accordance with the ISO 10993 family of standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for the mechanical property bench tests or biocompatibility tests. It broadly states that "bench testing was performed" and "biocompatibility tests have been performed."
- Data Provenance: The tests were conducted to support a submission by Osstem Germany GmbH. While the exact location of the testing is not specified, it's likely that the tests were performed by the manufacturer or a third-party laboratory. The data would be retrospective in nature, generated specifically for this premarket submission. No information on country of origin of the data is provided beyond the submitting company's location (Germany) and correspondent's location (USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document.
Given that this is a material science study focusing on physical properties and biocompatibility, "experts" in the traditional clinical sense (like radiologists) are not typically involved in establishing ground truth for such bench tests. The "ground truth" is typically defined by the test methods themselves (e.g., ISO standards), with results verified by qualified laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method like 2+1 or 3+1. This is expected as the evaluation relies on objective, standardized physical and chemical tests rather than subjective human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for medical imaging AI algorithms where human readers (e.g., radiologists) interpret images with and without AI assistance. This device is an impression material, not an AI or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study of an algorithm was done. This device is an impression material, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily based on:
- International Standards: Specifically, the ISO 10993 family for biocompatibility and ISO 4823 for impression materials mechanical properties. These standards define the methodologies and expected ranges for various material characteristics.
- Comparison to Predicate Devices: The "comparable to other materials on the market" and "compared to leading Impression materials" statements indicate that the performance of legally marketed predicate devices serves as a practical "ground truth" or benchmark for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical material, not a machine learning model. Therefore, there is no "training set." The testing performed relates to material properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question does not apply to this device.
§ 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).