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

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.

AI/ML Overview

The provided text describes a 510(k) summary for a dental impression material named Vonflex™ Heavy/ Vonflex™ Light. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical measures from a study proving device performance is not explicitly available in this document.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria for performance are not explicitly stated as quantitative metrics with pass/fail thresholds in this summary. Instead, the summary asserts "similar characteristics" to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Use Concept	Vonflex™ Heavy/ Vonflex™ Light has similar characteristics as the predicate device (Aquasil ultra rigid smart wetting impression material, K021413; Aquasil ultra Iv smart wetting impression material, K021416).
Flow Properties	Vonflex™ Heavy/ Vonflex™ Light has similar characteristics as the predicate device.
Setting Time	Vonflex™ Heavy/ Vonflex™ Light has similar characteristics as the predicate device.
Compatibility with Die and Cast Materials	Vonflex™ Heavy/ Vonflex™ Light has similar characteristics as the predicate device.
Safety (Biocompatibility)	"Safety tests including biocompatibility have been conducted." (No specific results or acceptance criteria are detailed, but the conclusion states the device is "safe and effective.")
General Performance	"Vonflex™ Heavy/ Vonflex™ Light has been subjected to extensive safety, performance, and product validations prior to release." (No specific metrics or targets are provided, but the conclusion states the device is "safe and effective" and "substantially equivalent" to the predicate.)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified. The submission is from Vericom Co., Ltd. in the Republic of Korea. It implies that any testing would have been conducted by the manufacturer or a contracted lab. The document does not indicate if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the submission focuses on demonstrating equivalence to a predicate device through non-clinical characteristics rather than a study requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not provided.

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 device (dental impression material) is a physical, passive material and does not involve AI or human readers in the context described for an MRMC study. Therefore, an MRMC study was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device does not involve an algorithm. Therefore, a standalone algorithm performance study was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic AI/imaging devices is not directly applicable here. The evaluation of this device would involve physical and chemical property testing (e.g., rheology, setting time, dimensional stability, biocompatibility) rather than diagnostic accuracy against a ground truth diagnosis.

8. The sample size for the training set

This device does not involve a "training set" in the context of an algorithm or statistical model. The term is not applicable.

9. How the ground truth for the training set was established

As in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of medical device submission.

Summary

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Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

510(k) Summary

K103164

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

1. Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	#606, 5th Dongyoung Venturestel199-32, Anyang 7-Dong, Manan-GuAnyang-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:

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.

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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: <

7 Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Vericom Co., Ltd.
concludes that Vonflex™ Heavy Vonflex™ Light is isafe and effective and s
1. Vericom Co., Ltd., will update and include in this summary any other information deemed
  reasonably necessary by the FDA.
  END

606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

Image /page/1/Picture/12 description: The image shows a logo for a company called VERICOM. Below the company name, the words "Dental materials" are written in a smaller font. The logo is black and white and has a simple design.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, abstract style, with thick black lines forming its shape. The text is in a smaller font size and is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vericom Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington DC 38607-9526

NOV 1 0 2010

Re: K103164

Trade/Device Name: VonflexTM Heavy VonflexTM Light Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: EL W Dated: October 5, 2010 Received: October 27, 2010

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Mouser

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Pumpos

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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510(k) Submission - Vonflex™ Heavy/ Vonflex™ Light

510(k) Number K ______________________________________________________________________________________________________________________________________________________________

NOV 1 0 2010

Device Name: Vonflex™ Heavy/ Vonflex™ Light

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

Prescription Use	✓
(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)

Signature

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K103164
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Regulation Number and Section

§ 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).