Vonflex™ Putty, 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 shrinkage, helping to make precise impression taking.

AI/ML Overview

This 510(k) summary describes a dental impression material, Vonflex™ Putty, and its substantial equivalence to a predicate device, Panasil Putty Soft. The document focuses on demonstrating that the new device has similar characteristics and performs as safely and effectively as the existing one.

Here's an analysis of the provided text in relation to the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for flow properties, setting time). Instead, it uses qualitative statements to claim similarity to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Claim)
Use concept	Vonflex™ Putty has similar characteristics as the predicate device regarding "Use concept."
Flow properties	Vonflex™ Putty has similar characteristics as the predicate device regarding "Flow properties."
Setting time	Vonflex™ Putty has similar characteristics as the predicate device regarding "Setting time."
Compatibility with die/cast	Vonflex™ Putty has similar characteristics as the predicate device regarding "Compatibility with the die and cast materials."
Biocompatibility	Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any testing. It states that "Vonflex™ Putty has been subjected to extensive safety, performance, and product validations prior to release" and that "Safety tests including biocompatibility have been performed."

The manufacturer, Vericom Co., Ltd., is located in the Republic of Korea. Therefore, the data provenance is likely Republic of Korea, and given the context of product validation prior to release, the studies would be prospective in nature.

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 information is not provided in the document. The submission relies on comparative claims with a predicate device and mentions "safety, performance, and product validations," but does not detail the methodology or expert involvement for establishing ground truth for any specific test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a dental impression material, not an AI-based device that would involve human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This submission is for a physical dental impression material, not a software algorithm or AI.

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

The document primarily relies on physical and chemical property comparisons to a predicate device. The "ground truth" for a dental impression material would be its ability to accurately replicate oral tissue shape, its stability, and its biocompatibility. While expert assessment is implicitly part of "product validations," the specific type of ground truth (e.g., measured accuracy against known standards, expert evaluation of impression quality) is not detailed. Biocompatibility would rely on standard in-vitro and potentially in-vivo tests, with "ground truth" established by compliance with international regulations.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that would require a "training set."

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

This information is not applicable for the same reason as above.

Summary

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K091267

000019

Page 1 of 2

Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

6 2009

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 2, 2009

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™ Putty Common Name - Impression Materials Classification Name - Material, Impression

3. Predicate Device:

Panasil putty soft, Kettenbach GmbH & Co. KG, K082560

1. Description:
  Vonflex™ Putty, 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 shrinkage, helping to make precise impression taking.

5. Indication for use:

Two step putty/wash impression technique
One step putty/wash impression technique
Two step putty/wash impression technique using a foil (plastic putty spacer)
One step putty impression technique for forming functional peripheries

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606,5 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 a logo for a company called "VERICOM" that produces dental materials. The logo is in black and white and features the company name in a stylized font. Below the company name, the words "Dental materials" are written in a smaller font. The logo has a curved shape.

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Healthy and beautiful teeth with Vericom

Page 2 of 2

1. Review:
  Vonflex™ Putty has the similar characteristics as the predicate device; Use concept, Flow properties, Setting time, and Compatibility with the die and cast materials.

のおいしかない。・・・

Vonflex™ Putty has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

1. 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™ Putty is safe and effective and substantially equivalent to predicate devices as described herein.
1. Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

Image /page/1/Picture/10 description: The image contains an address. The address is # 606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea. The address appears to be a business address in Korea.

Image /page/1/Picture/11 description: The image shows the word "VERICOM" in a stylized font, with the words "Dental materials" underneath. The word "VERICOM" is in all caps and is set inside of a black shape. The words "Dental materials" are in a smaller font and are centered below the word "VERICOM".

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vericom Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

Re: K091267 Trade/Device Name: VonflexTM Putty Regulation Number: 21 CFR 872.3660 Regulatory Class: II Product Code: ELW Dated: March 20, 2009 Received: April 30, 2009

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 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.

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Page 2- Mouser

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Reeves

Susan Runner, D.D.S., M.A. Acting 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™ Putty

000018

510(k) Number K _

Device Name: Vonflex™ Putty

Indication for use:

Two step putty/wash impression technique -
One step putty/wash impression technique -
Two step putty/wash impression technique using a foil (plastic putty spacer) -
One step putty impression technique for forming functional peripheries -

Prescription Use OR
(Per 21CFR801.109)

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: KC91267

Vericom Co., Ltd. 4. Indications for use Page # 1 of 1

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).