(6 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a flowable restorative resin, with no mention of AI or ML capabilities.
No
The device is a restorative resin used to fill cavities and repair teeth, which is a treatment, but it is not intended to cure or prevent diseases, nor restore or modify body functions, which are characteristics of a therapeutic device.
No.
The device is described as a light-cured radio-opaque flowable restorative resin used for filling cavities and repairing dental restorations, which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "light-cured radio-opaque flowable restorative resin" composed of various materials, indicating it 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 clearly describes the device as a restorative material for dental procedures (filling cavities, sealing fissures, repairing veneers). This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description details the composition and properties of a dental resin used for filling and restoring teeth. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of providing information about a patient's health status, disease, or condition through in vitro testing.
In summary, DenFil™ flow is a dental restorative material used directly on the patient's teeth for treatment purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Class V restorations (cervical caries, root erosion, wedge shaped defects)
- Anterior restorations (Class III, IV)
- Small posterior restorations
- Restorative therapy for mini-cavities of all types
- Extended fissures sealings in molars and premolars
- Repair of composite/ceramic veneers
- Blocking out of undercuts
Product codes
EBF
Device Description
DenFil™ flow is a light-cured radio-opaque flowable restorative resin. It is composed of Epoxyacrylate(Bis-GMA), Diurethane dimethacrylate, Triethyleneglycol dimethacrylate, Barium aluminosilicate and other materials. As DenFil™ flow has a lower viscosity than paste type composite resin-Flow; 0.16 mm/30sec, so it can restore narrow & deep cavity easily. DenFil™ flow can be applied to fill cavities of all types exactly and efficiently by using a disposable tip. And DenFil™ flow has various shade that correspond to the most common used shading system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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™ flow has the similar technological characteristics as the predicate device; main material, chemical composition, Radiopaque, visible light activate and design.
DenFil™ flow has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow, film thickness, wear, polymerization shrinkage and thermal expansion coefficience.
DenFil™ flow 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)
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
000011
Page 1 of 2
Vericom Co. Ltd.
Healthy and beautiful teeth with Vericom
510(k) Summary
Whit 16 ...
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 |
- Device :
Proprietary Name - DenFil™ flow Common Name - Dental Composites and Filling Materials Classification Name - Material, Tooth Shade, Resin
-
- Predicate Device : Tetric Flow, IVOCLAR NORTH AMERICA, INC. K993783
-
- Description :
DenFil™ flow is a light-cured radio-opaque flowable restorative resin. It is composed of Epoxyacrylate(Bis-GMA), Diurethane dimethacrylate, Triethyleneglycol dimethacrylate, Barium aluminosilicate and other materials. As DenFil™ flow has a lower viscosity than paste type composite resin-Flow; 0.16 mm/30sec, so it can restore narrow & deep cavity easily. DenFil™ flow can be applied to fill cavities of all types exactly and efficiently by using a disposable tip. And DenFil™ flow has various shade that correspond to the most common used shading system.
-
- Indication for use :
- Class V restorations (cervical caries, root erosion, wedge shaped defects)
- Anterior restorations (Class III, IV)
- Small posterior restorations
- Restorative therapy for mini-cavities of all types
- Extended fissures sealings in molars and premolars
- Repair of composite/ceramic veneers
- Blocking out of undercuts
気になるとはなくなると、それではないというとなったりしています。 この日は、 この日は、 この
-
- Review :
DenFil™ flow has the similar technological characteristics as the predicate device; main material, chemical composition, Radiopaque, vi sible light activate and design.
- Review :
606,5% Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/0/Picture/26 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
Image /page/1/Picture/0 description: The image contains a sequence of digits, specifically '000012'. The digits are arranged horizontally, with the zeros appearing at the beginning, followed by a one and a two. The numbers are presented in a simple, straightforward manner, without any additional context or formatting.
Page 2 of 2
Vericom Co. Ltd. K8600 H350 W 600 B SS 15 - 10 1 2 2 10 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Healthy and beautiful teeth with Vericom
DenFil™ flow has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow, film thickness, wear, polymerization shrinkage and thermal expansion coefficience.
DenFil™ flow 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, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification Vericom Co., Ltd. concludes that DenFil™ flow 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.
14 Holler Particolous Contraliand Comments on Selling and Services and Comments of Section and
606,5% Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea
Image /page/1/Picture/11 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in white, bold letters, set against a black, curved background. Below the logo, the words "Dental materials" are printed in a smaller, sans-serif font.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of an eagle or bird-like symbol. The symbol consists of three curved lines that resemble wings or feathers. The logo is surrounded by text, which is partially illegible due to the image quality. The text appears to be arranged in a circular fashion around the bird symbol. The logo is simple and abstract, with a focus on the bird-like imagery.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2008
Vericom Company, Limited C/O Mr. John Howlett British Standards Institution Product Services Maylands Avenue Hemel Hempstead United Kingdom HP2 4QS
Re: K060637
Trade/Device Name: DenFilTMflow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: March 10, 2006 Received: March 10, 2006
Dear Mr. Howlett:
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 increations for ass barror 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 Amendments, or to de roos 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 approvial applisions of the Act. The general controls provisions of the Act include controls provision 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 (1111), it inch 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. John Howlett
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 nioan that or any Federal statutes and regulations administered by other Federal agencies. or the Act of any 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 and insting (21 OF Privation) (QS) regulation (QS) regulation (21 CFR Part 820); and if ropiicable, 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) I mo leter 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), If you desire specific at 110 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,
Chih 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
Indications for Use
0000 0
510(k) Number (if known) _ KOGO (0 Z7
Device Name: DenFil™ flc"v
Indications For Use:
- Class V restorations (cervical caries, root erosion, wedge shaped defects)
- Anterior restorations (Class III, IV)
- Small posterior restorations
- Restorative therapy for mini-cavities of all types
- Extended fissures sealings in molars and premolars
- Repair of composite/ceramic v୍элееrs
- Blocking out of undercuts
Prescription Use AND/OR Over-The-Counter Use (21CFR801 Subpart D) (21CFR801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pislogy General Huspic
confol Dental Devices
R0600637