(14 days)
No
The description focuses on the material properties and physical characteristics of a root canal filling paste, with no mention of AI or ML.
No.
Well-Paste is a temporary root canal filling material and sealer, not a therapeutic device designed to treat or cure a disease.
No
Well-Paste™ is a root canal sealer used for temporary filling, not for diagnosing conditions. Its description focuses on its material properties and application as a filling material.
No
The device description clearly states it is a "temporary root canal filling material" and lists physical components like "Calcium Hydroxide and Barium Sulfate," a "syringe," "disposable tips," a "plastic holder," and a "disposable tip cap." This indicates it is a physical material and delivery system, not software.
Based on the provided information, Well-Paste™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Well-Paste™ is a root canal sealer used for filling root canals within the body (in vivo).
- IVDs are used to provide information about a physiological state, health, or disease. Well-Paste™ is a therapeutic device used to fill and seal root canals, not to diagnose or provide information about a patient's health status.
The description focuses on the physical properties and application of the material within the root canal, which is consistent with a medical device used for treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.
Product codes
KIF
Device Description
Well-Paste™ is a temporary root canal filling material after endodontic surgery as pulp capping, pulpotomy or apexification. It contains Calcium Hydroxide and Barium Sulfate mainly, so it shows excellent radiopacity. It also has high fluidity and excellent accessibility into the root canal. Well-Paste™ is premixed paste as a non-setting material and is very stable without any solidification 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-Paste™ has the similar technological characteristics as the predicate device; device design, appearance, main materials and indication for use.
Well-Paste™ has the similar physical properties as the predicate device; flow, film thickness, radiopacity, solubility and disintegration.
Well-Paste™ 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)
Metapaste, META BIOMED CO. LTD. K032605
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
Healthy and beautiful teeth with Vericom
510(k) Summary
Kogomd
APR 2.1 2009
000018
Page 1 of 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: December 1, 2008
- 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 |
- Device :
Proprietary Name - Well-Paste TM Common Name - Root canal filling Materials Classification Name - Resin, Root Canal Filling
-
- Predicate Device : Metapaste, META BIOMED CO. LTD. K032605
-
- Description :
Well-Paste™ is a temporary root canal filling material after endodontic surgery as pulp capping, pulpotomy or apexification. It contains Calcium Hydroxide and Barium Sulfate mainly, so it shows excellent radiopacity. It also has high fluidity and excellent accessibility into the root canal. Well-Paste™ is premixed paste as a non-setting material and is very stable without any solidification or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.
-
- Indication for use :
Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canal after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectornies in deciduous teeth.
- Indication for use :
606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
September 1998 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199
Image /page/0/Picture/18 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, in a smaller font, are the words "Dental materials."
1
000019
6. Review :
Well-Paste™ has the similar technological characteristics as the predicate device; device design, appearance, main materials and indication for use.
Well-Paste™ has the similar physical properties as the predicate device; flow, film thickness, radiopacity, solubility and disintegration.
Well-Paste™ 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.
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 Well-Paste™ is safe and effective and substantially equivalent to predicate devices as described herein.
-
- 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.
606,5th 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 that produces dental materials. The logo consists of the word "VERICOM" in bold, white letters on a black, curved background. Below the word "VERICOM" is the phrase "Dental materials" in a smaller, sans-serif font. The logo is simple and professional, and it clearly communicates the company's focus on dental products.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2009
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: K090992
Trade/Device Name: Well-Paste™ Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: March 12, 2009 Received: April 7, 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.
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.
3
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 Suarez
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
000017
510(k) Number K
Device Name: Well-Paste™
Indication for use:
Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.
Prescription Use OR (Per 21CFR801.109)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Turner
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
-10(k) Number: K080991
Vericom Co., Ltd.
- Indication for use Page # 1 of 1