(89 days)
HySil Putty is to be used as preliminary materials for:
- Two-step Putty-wash impression technique .
- · One-step Putty-wash impression technique
HySil Heavy is 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
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions 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
HySil Light is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique .
- · One-step putty-wash impression technique
- · Two-step impression technique using dual viscosities
- · Reline impressions
- · Fabricating full or partial dentures
HySil Extra Light is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique .
- · One-step putty-wash impression technique
- · Two-step impression technique using dual viscosities
- · Reline impressions
- Fabricating full or partial dentures
HySil Bite is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- · Recording after putting the articulator
HySil Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars.
Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated.
This is a 510(k) premarket notification for a dental impression material, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility.
Here's the information that can be extracted from the provided text, aligning with the categories where applicable for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
For HySil Extra Light and HySil Putty (ISO 4823 and ISO 10993 family):
| Performance Characteristic | Acceptance Criterion (Predicate) | Reported Device Performance (HySil Extra Light) | Reported Device Performance (HySil Putty) |
|---|---|---|---|
| Component Colour | Pass | Pass | Pass |
| Weight (Volume) test | Pass | Pass | Pass |
| Package | Pass | Pass | Pass |
| Consistency | 45.03mm (Light), 26.86mm (Putty) | 44.61mm | 31.27mm |
| Working Time | 2.25 min (Light) | 3.6 min | - |
| Mixing Time | 25 sec (Putty) | - | 38 sec |
| Detail Reproduction | Pass | Pass | Pass |
| Compatibility with Gypsum | Pass | Pass | Pass |
| Linear Dimensional change | 0.04% | 0.027% | 0.031% |
| Elastic Recovery | 98.33% (Light), 97.78% (Putty) | 99.5% | 99.8% |
| Strain-in-Compression | 3.87% (Light), 4.70% (Putty) | 2.6% | 1.6% |
| Cytotoxicity | Pass | Pass | Pass |
| Oral Irritation | Pass | Pass | Pass |
| Maximization and Sensitization | Pass | Pass | Pass |
For HySil Bite (DIN 13903 and ISO 10993 family):
| Performance Characteristic | Acceptance Criterion (Predicate) | Reported Device Performance (HySil Bite) |
|---|---|---|
| Colours | Pass | Pass |
| Working Time (Processing Time) | Pass | Pass |
| Minimum Period Spent in the Mouth | 1 min. 30 sec | 1 min. 30 sec |
| Recovery after Deformation | more than 0.1mm | more than 0.1mm |
| Load Endurance during Bending | Pass | Pass |
| Hardness Degree (HD) | More than 20 HD (Predicate values: 74 HD, 72 HD, 70 HD, 64 HD, 70 HD) | 50 HD |
| Linear Dimensional Change | shall be within ± 1.5 % (Predicate values: 0.00%, 0.00%, 0.10%, 0.10%, 0.02%) | - 0.16 % |
| Cytotoxicity | Pass | Pass |
| Oral Irritation | Pass | Pass |
| Maximization and Sensitization | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- The document implies that testing was performed on the HySil Impression Materials as the "subject device" against predicate devices.
- The exact sample sizes for each specific test (e.g., how many specimens were tested for linear dimensional change) are not explicitly stated in the provided text.
- Data Provenance: The manufacturer is Osstem Implant Co., Ltd., located in Busan, Republic of Korea. The testing was conducted as part of their 510(k) submission, suggesting it was internal testing by the manufacturer or a contracted lab. The data would be considered prospective as it was generated to support this specific regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable as the submission is for a material, not an AI/ML device that generates diagnoses or interpretations requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as this is not an AI/ML device involving human interpretation requiring adjudication.
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:
- This question is not applicable as this is not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This question is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and mechanical properties, the "ground truth" or acceptance criteria are based on recognized international standards:
- ISO 4823 for general impression materials.
- DIN 13903 for jaw relation recording materials (HySil Bite).
- For biocompatibility, the "ground truth" is based on ISO 10993 family standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation).
- The device performance is compared directly to the specified requirements within these standards and the reported performance of legally marketed predicate devices.
8. The sample size for the training set:
- This question is not applicable as this is not an AI/ML device. No training set was used.
9. How the ground truth for the training set was established:
- This question is not applicable as this is not an AI/ML device. No training set was used.
§ 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).