(5 days)
Not Found
No
The device description and intended use clearly indicate a chemical etching agent, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device, DenFil™ Etchant-37, is described as an etching agent used to prepare tooth surfaces for adhesive restorations, which is a structural rather than a therapeutic function.
No
Explanation: This device, DenFil™ Etchant-37, is described as an etching agent used for preparing tooth cavities for adhesive restorations. Its function is to etch enamel and dentin to improve retention of a restoration, which is a therapeutic or restorative action, not a diagnostic one.
No
The device description clearly states it is an "etching agent consists of 37% phosphoric acid formulations thickened with natural polymer," which is a chemical 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 "Etching the enamel and dentine for adhesive restorations." This is a procedure performed directly on the tooth within the patient's mouth, not on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description clearly states it's an "etching agent" applied to the tooth to improve restoration retention. It's classified under a regulation for "tooth shade resin material," which is a dental device used directly on the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, DenFil™ Etchant-37 is a dental device used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Etching the enamel and dentine for adhesive restorations.
Product codes
EBF
Device Description
DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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)
DenFil™ Etchant-37 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 Internation and US regulations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Ko80265
000015
2007 2008
Vericom Co. Ltd.
Healthy and beautiful teeth with Vericom
Page 1 of 2
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: September 1, 2007
- 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 - DenFil™ Etchant-37 Common Name - Etching agent Classification Name - Material, Tooth Shade, Resin
- Predicate Device:
K-ETCHANT GEL, KURARAY MEDICAL INC, K062409
4. Description:
DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations
thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a
prepared cavity of a tooth to improve retention of a restoration.
- Indication for use:
Etching the enamel and dentine for adhesive restorations.
に、そのあると、そのため、このと、この、ここで、
606,50 Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/19 description: The image shows a logo for Vericom Dental Materials. The logo is black and white and features the word "VERICOM" in a stylized font. Below the word "VERICOM" are the words "Dental materials" in a smaller font. The logo is simple and professional, and it is likely used to promote Vericom Dental Materials and its products.
1
000016
Page 2 of 2
Vericom Co. Ltd. Company Comments of Children Comments of
Healthy and beautiful teeth with Vericom
6. Review:
DenFil™ Etchant-37 has the same device characteristics as the predicate device; main material, chemical composition, and use concept.
DenFil™ Etchant-37 has the similar mechanical properties as the predicate device; pH, adhesion and viscosity.
DenFil™ Etchant-37 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 Internation 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 DenFam Etchant-37 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.
CI Car 2019 Catalia 2011 - 14
606,5m 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 Dental materials". The logo is in black and white and features the company name in a stylized font. The words "Dental materials" are written in a smaller font below the company name. The logo has a curved shape.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of thick, black lines.
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: K080265
Trade/Device Name: DenFil™ Etchant-37 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF 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,
Chiu Lin, Ph.D.
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
000011
510(k) Submission - DenFill™ Etchant-37
510(k) Number K080305
Device Name: DenFil™ Etchant-37
Indication for use:
Etching the enamel and dentine for adhesive restorations. .
Prescription Use (Per 21CFR801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vericom Co., Ltd.
Susan Ruoves
Division Sign-Off)
Jivision of Anesthesists
- Indication for use Page # 1 of 1
Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
10(k) Number: TO 800