Vonflex S Putty

• K Number: K152518
• Device Name: Vonflex S Putty
• Manufacturer: VERICOM CO., LTD
• Date Cleared: 2015-11-30 ( 88 days)
• Product Code: ELW
• Regulation Number: 872.3660

Intended Use

It is used for all crown, bridge and orthodontic impression techniques.

Device Description

Vonflex S™ Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.

Predicate Devices

K103346

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and biocompatibility properties of a silicone impression material, with no mention of AI or ML.

Therapeutic

No.
The device is used for taking impressions of oral tissue, which is a diagnostic or procedural step, not a therapeutic intervention to treat or prevent a disease.

Diagnostic

No

This device is an impression material used to create molds of oral tissue. Its purpose is to physically replicate anatomical structures for restorative or orthodontic procedures, not to detect or analyze medical conditions for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "vinyl polysiloxane impression material," which is a physical material used for taking dental impressions, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "all crown, bridge and orthodontic impression techniques." This describes a physical process of creating a mold of oral tissue.
• Device Description: The device is described as a "vinyl polysiloxane impression material." This is a material used to take physical impressions.
• Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of a specimen. It is used to create a physical impression of the oral tissue, not to analyze the tissue itself.
• Performance Studies: The performance studies focus on physical properties and biocompatibility, which are relevant for a material used in the mouth, but not for an IVD.

Therefore, Vonflex S™ Putty is a dental impression material, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

It is used for all crown, bridge and orthodontic impression techniques.

Product codes (comma separated list FDA assigned to the subject device)

ELW

Device Description

Vonflex STM Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps 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)

Biocompatibility tests have been performed to assure biological safety in consideration of the ISO 10993. Vonflex S™ Putty is tested through the following test: Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) and In vitro genotoxicity (Ames test) (ISO 10993-3). The conclusion of the assessments is that Vonflex S™ Putty is biocompatible for its intended use. Performance testing against ISO 4823 includes: Classification (Type 0), Dimensional accuracy (Max.1.5%), Consistency (Max. 35mm), Compatibility with the die and cast materials (75μm reproduction), and Curve of the shrinkage (Strain in compression) (Min.0.8 ~ Max.20%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103346

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

November 30, 2015

Vericom Co., Ltd. Myung-Hwan Oh R&D Center, Dental 48, Toegyegongdan 1-Gil Chuncheon-si, Gangwon-Do 200-944 REPUBLIC OF KOREA

Re: K152518

Trade/Device Name: Vonflex S Putty Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 28, 2015 Received: September 3, 2015

Dear Myung-Hwan Oh:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K _152518

Device Name: Vonflex S™ Putty

Indication for use:

It is used for all crown, bridge and orthodontic impression techniques.

Prescription Use OR (Per 21 CFR Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

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

Date: July 28, 2015

• 1. Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	48, Toegyegongdan 1-Gil,
Chuncheon-Si, Gangwon-Do,
Republic of Korea 200-944
Phone	[phone]
Fax	[phone]
Contact	Myung-Hwan Oh
[e-mail]
Internet	www.vericom.co.kr

2. Device:

Proprietary Name - Vonflex STM Putty Common Name - Impression Materials Classification Name - Material, Impression

• 3. Predicate Device:
     Delikit Putty, Sherpa Korea, K103346
• 4. Description:
     Vonflex STM Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.
• 5. Indication for use:
     It is used for all crown, bridge and orthodontic impression techniques.

48, Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do 200-944, Korea

Image /page/3/Picture/16 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters inside of a red curved shape. Below the curved shape are the words "Dental materials" in a smaller, sans-serif font.

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• 6. Technological Characteristics and Performance Testing:
     Vonflex S™ Putty has compared to the predicate device with regard to indications for use, physical properties and etc. The evaluation items are in accordance with the requirements of ISO 4823. According to the test results, Vonflex S™ Putty is substantially equivalent to the predicate device.

Biocompatibility tests have been performed to assure biological safety in consideration of the ISO 10993. Vonflex S™ Putty is tested through the following test: Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) and In vitro genotoxicity (Ames test) (ISO 10993-3). The conclusion of the assessments is that Vonflex S™ Putty is biocompatible for its intended use.

Comparison table

	Subject Device	Predicate Device	Summary
510(K)
Number	N/A	K103346	-
Proprietary
name	Vonflex S™ Putty	Delikit Putty	-
Manufacturer	VERICOM CO., LTD.	Sherpa Korea
Indications
for use	It is used for all crown,
bridge and orthodontic
impression techniques.	It is an addition-cure
vinyl polysiloxane dental
impression material that is
used for all crown and
bridge, edentulous,
orthodontic and implant
impression techniques.	The indication for use
of the subject and
predicate device is to
make impression
taking, but it is not
limited to the
applications listed in
the indications for
use.
Standard
conformed	ISO4823	ISO4823	Claims are the same
Physical
properties	- Classification according to
ISO4823: Type 0

• Dimensional accuracy:
  Max.1.5%
• Consistency: Max. 35mm
• Compatibility with the die
  and cast materials:
  75μm reproduction
• Curve of the shrinkage
  (Strain in compression):
  Min.0.8 ~ Max.20% | - Classification according
  to ISO4823: Type 0
• Dimensional accuracy:
  Max. 1.5%
• Consistency: Max.35mm
• Compatibility with the die
  and cast materials:
  75μm reproduction
• Curve of the shrinkage
  (Strain in compression):
  Min.0.8 ~ Max.20% | The classification of
  the subject and
  predicate device is
  complied with ISO
  4823 (Type 0).
  According to the
  description and
  bench test result, the
  physical properties of
  the subjective
  devices are similar to
  these of the
  predicate device. |
  | Raw Material | Vinyl polysiloxane | Vinyl polysiloxane | Claims are the same |
  | Mixing Ratio | 1:1 | 1:1 | Claims are the same |
  | Method of
  Manipulation | Hand-kneaded mixes | Hand-kneaded mixes | Claims are the same |

48, Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do 200-944, Korea

Image /page/4/Picture/8 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters on a red, curved background. Below the logo, the words "Dental materials" are written in a smaller, black font.

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

Image /page/5/Picture/6 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white letters inside of a red curved shape. Below the red shape, the words "Dental materials" are written in a smaller, black font.