(5 days)
Not Found
No
The description focuses on the material properties and intended use of a root canal sealer, with no mention of AI or ML capabilities.
Yes
The intended use explicitly states its purpose is "to stimulate healing process," "to promote healing effects," and "to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete," which are therapeutic actions.
No
Well-Pex™ is a root canal sealer and filling material used for treatment, not for diagnosing conditions. Its purpose is to stimulate healing, prevent contamination, and aid in tissue induction and deposition.
No
The device description clearly states that Well-Pex™ is a premixed paste packaged in a syringe with disposable tips, a plastic holder, and a disposable tip cap, indicating it is a physical material and associated hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used within the body (in the root canal) to stimulate healing, prevent contamination, and assist in the filling process. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description reinforces that it's a "temporary root canal filling material" and a "premixed paste" for use in the root canal.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information for diagnosis. The device itself is the treatment material.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Well-Pex™ is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
Well-Pex™ is a temporary root canal filling material after pulpectomy, or for apexogenesis or velifeex is a temporaly root contriming material and the treatment of infected root canals. apexinciation. It is also docu as a good finance shows excellent radiopacity and prevention of microbial contamination. It has high fluidity and excellent accessibility into the root canal. Well-Pex™ is a premixed paste as a non-setting material and is very stable without any soliditication or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
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)
Well-Pex™ 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.
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
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Vericom Co. Ltd. ンク
Healthy and beautiful teeth with Vericom
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: ________________________________________________________________________________________________________________________________________________________________________
- 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 |
FEB - 6
- Device :
Proprietary Name - Well-Pex™ Common Name - Root canal filling Materials Classification Name - Resin, Root Canal Filling
- Predicate Device :
Metapex, META BIOMED CO. LTD. K032603
4. Description :
··············································································································································································
Well-Pex™ is a temporary root canal filling material after pulpectomy, or for apexogenesis or velifeex is a temporaly root contriming material and the treatment of infected root canals. apexinciation. It is also docu as a good finance shows excellent radiopacity and prevention of microbial contamination. It has high fluidity and excellent accessibility into the root canal. Well-Pex™ is a premixed paste as a non-setting material and is very stable without any soliditication or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.
606,5% Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/17 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 "VERICOM" are the words "Dental materials" in a smaller, serif font. The logo is black and white.
1
Vericom Co. Ltd.
Healthy and beautiful teeth with Vericom
- Indication for use :
Well-Pex™ is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filing with gutta-percha.
- Review :
Well-Pex™ has the similar technological characteristics as the predicate device; device design, appearance, main materials and indication for use.
Well-Pex™ has the similar physical properties as the predicate device; flow, film thickness, Radiopacity, slubility and disintegration.
Well-Pex™ 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 :
ln 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 Well-Pex™ 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.
606,56 Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/1/Picture/14 description: The image shows a logo for a company called "VERICOM". Below the logo, the words "Dental materials" are printed in a smaller font. The logo is black and white and has a stylized design.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vericom Company Limited C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 455 East Trimble Road San Jose, California 95131-1230
Re: K080266
Trade/Device Name: Well-PexTM Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 22, 2008 Received: February 1, 2008
Dear Mr. Christensen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Christensen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CluR
Chiu Lin, Ph.D. 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) Number K ( -
Device Name: Well-Pex™
Indication for use:
Well-Pex™ is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
Prescription Use OR Over-The-Counter Use (Per 21CFR801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vericom Co., Ltd
- Indication for use Page # 1 of 1
Suen Ringer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Y020666
00-MB-F0031 - Rev. 2.1