(14 days)
Not Found
No
The description focuses on the material properties and handling characteristics of a traditional impression material, with no mention of AI or ML.
No
The device is described as an impression material used for capturing the shape of oral tissue, which is a diagnostic or procedural aid, not a device intended to treat or cure a disease or condition.
No.
The device is described as an impression material for capturing the shape of oral tissue, which is used for creating models or impressions. It does not perform any diagnosis.
No
The device description clearly states it is a "rubber impression material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material's function in taking impressions of oral tissue for dental purposes. This is a physical process of capturing a mold, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the material's properties as a rubber impression material for accurately replicating oral tissue shape. It doesn't mention any analytical or diagnostic function.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific substances or markers
- Diagnosis, monitoring, or screening of diseases or conditions
This device is a dental impression material, which falls under the category of medical devices used for creating physical models of oral structures.
N/A
Intended Use / Indications for Use
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
- All impression techniques where the operator needs a heavy or low viscosity material
Product codes
ELW
Device Description
Vonflex™ Heavy/ Vonflex™ Light as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low deformation, helping to make precise impression taking,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Vonflex™ Heavy! Vonflex™ Light has the similar, characteristics as the predicate device; Use concept, flow properties, setting time and compatibility with the die and cast materials and so on.
Vonflex™ Heavy/ Vonflex™ Light has been subjected to extensive safety, performance volmex - Preavy, Tomics - Clynt his boom on the sts including biocompatibility, have and product validations prior to release. Safety tests including biocompatibility have regulations:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
000019
Page 1 of 2
Vericom Co. Ltd.
Healthy and beautiful teeth with Vericom
510(k) Summary
NOV 1 0 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 1, 2010
-
- Company making the submission:
| Submitter | |
|---|---|
| Name | VERICOM Co., Ltd. |
| Address | #606, 5th Dongyoung Venturestel |
| 199-32, Anyang 7-Dong, Manan-Gu | |
| Anyang-Si, Gyeonggi-Do, | |
| Republic of Korea 430-817 | |
| Phone | +82 31 441-2881 |
| Fax | +82 31 441-2883 |
| Contact | Myung-Hwan Oh |
| Internet | mh-oh@hanmail.net |
2. Device:
Proprietary Name - Vonflex™ Heavy/ Vonflex™ Light Common Name - Impression Materials Classification Name - Material, Impression
3. Predicate Device:
Aquasil ultra rigid smart wetting impression material, Dentsply Intl., K021413 Aquasil ultra Iv smart wetting impression material, Dentsply Intl., K021416
4. Description:
Vonflex™ Heavy/ Vonflex™ Light as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low deformation, helping to make precise impression taking,
5. Indication for use:
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- All impression techniques where the operator needs a heavy or low viscosity material
606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/23 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in bold, sans-serif font, arched upwards. Below the word is the phrase "Dental materials" in a smaller, serif font.
1
000020
Page 2 of 2
ericom Co. Ltd.
Healthy and beautiful teeth with Vericom
Review:
SVonflex™ Heavy! Vonflex™ Light has the similar, characteristics as the predicate device; Use concept, flow properties, setting time and compatibility with the die and cast materials and so on.
Vonflex™ Heavy/ Vonflex™ Light has been subjected to extensive safety, performance volmex - Preavy, Tomics - Clynt his boom on the sts including biocompatibility, have
and product validations prior to release. Safety tests including biocompatibility have regulations: ✓ |
|----------------------|-----------------------------------------------------------------|
| (Per 21CFR801.109) | |
| OR | |
| Over-The-Counter Use | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K103164 |
|---|---|
| ---------------- | --------- |