(6 days)
Not Found
No
The device description and intended use clearly describe a traditional dental impression material (silicone putty) and its application techniques. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is an impression material used for diagnostic purposes (making models of oral tissue), not for treating a disease or condition.
No
The device is described as an "impression material" used to "make oral tissue shape precisely," indicating its purpose is to create a physical mold for dental procedures, not to diagnose a condition or disease.
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 is for creating dental impressions of oral tissue. This is a physical process for capturing the shape of a biological structure, not for analyzing biological samples to diagnose a condition.
- Device Description: The description clearly states it's a "rubber impression material" used to "make oral tissue shape precisely." This aligns with a physical impression material, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Anatomical Site: While it interacts with oral tissue, it's for creating a physical mold, not for analyzing the tissue itself for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This device's function is purely mechanical – creating an impression.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device 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.
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™ 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.
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.
Panasil putty soft, Kettenbach GmbH & Co. KG, K082560
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
§ 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
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 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™ Putty Common Name - Impression Materials Classification Name - Material, Impression
3. Predicate Device:
Panasil putty soft, Kettenbach GmbH & Co. KG, K082560
-
- 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.
- Description:
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
、「、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、、
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.
1
Healthy and beautiful teeth with Vericom
Page 2 of 2
-
- 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.
- Review:
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.
-
- 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.
- Conclusions :
-
- Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
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".
2
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.
3
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
4
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