DENFIL

{0}------------------------------------------------ AUG 1 3 2004 K042124 001 File No. VR04/ ` Page 1 of 2 Vericom Co. Ltd. File No. 17611 Page 1 of 2 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: July 12, 2004 ### 1. Company: | | Company | |----------|----------------------------------------------------------------------------------------------------------------------------| | Name | VERICOM Co., Ltd. | | Address | #606, 5th Dongyoung Venturestel<br>199-32, Anyang 7-Dong, Manan-Gu<br>Anyang-Si, Gyeonggi-Do,<br>Republic of Korea 430-817 | | Phone | +82 31 441-2881 | | Fax | +82 31 441-2883 | | Contact | Myung-Hwan Oh | | Internet | omh@vericom.co.kr | ### 2. Device: Proprietary Name - DenFil™ Common Name - Dental Composites and Filling Materials Classification Name - Material, Tooth Shade, Resin # 3. Predicate Device: Clearfil AP-X, Kuraray Medical Inc., K012740 Clearfil AP-X PLT, Kuraray Medical Inc., K023002 Multiple, Dentsply Intl., K863092 . . ## 4. Classifications Names & Citations: 21CFR 872.3690, EBF, Material, Tooth shade, Resin, Class2 Guidance for the Preparation of Premarket Notifications for Dental Composites - 5. Description: DenFillM is light-cured restorative hybrid composite resin and accessories for use in both Posterior and Anterior restoration 6. Indication for use: - 1. Class I , II , V restorations of posterior teeth - 2. Class III, IV, IV, V restorations of anterior teeth - Cervical cavities or defects involving root surfaces 3. # 606,56) Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Kyunggi-do 430-817, Korea ! Image /page/0/Picture/25 description: The image shows the logo for VERICOM Dental materials. The logo is in black and white. The word "VERICOM" is in bold, sans-serif font and is placed inside of a black shape that resembles a smile. Below the logo, the words "Dental materials" are written in a smaller, sans-serif font. {1}------------------------------------------------ : 11117 Healthy and beautiful teeth with Vericom ### Vericom Co. Ltd. ・・ # 7. Contra-indications: Patients with allergies to methacrylate monomers. ## 8. Review: . 25984 : 255 : 14. - ... . . DenFill " has the same device characteristics as the predicate device Material, design and use concept is similar. DenFil™ has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations. An extensive review of literature perfaining to the safety and biocompatibility of DenFill " has been conducted. Appropriate safeguards have been incorporated in the design of DenFil™ # 9. 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™ is safe and effective and substantially equivalent to predicate devices as described herein. - 10. Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA. END # 606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Kyunggi-do 430-817, Korea Image /page/1/Picture/15 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 that resembles a smile. 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 seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healing. The seal is presented in black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 3 2004 Vericom Company, Limited C/O Mr. Marc M. Mouser Office Coordinator Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542 Re: K042124 Trade/Device Name: Denfil™M Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 27, 2004 Received: August 6, 2004 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 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. 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 mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regulaments, including, but not limited to: registration r ou must comply with an are Habeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ion 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 mis letter will and in yourse begant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - premiarket notification. - The 2 Dr Frisalts 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 no at (301) 594-4618. 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 may overni other generational 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/dsma/dsmamain.html Sincerely yours, Rei Muhey for Chin 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}------------------------------------------------ | 510(k) Number K | K042124 | |-----------------|---------| | Device Name: | DenFil™ | Indication for use: DenFil™ is indicated for the following restorative applications; 1. Class: I, II, V restorations of posterior teeth 2. Class III, IV, V restorations of anterior teeth 3. Cervical cavities or defects involving root surfaces | Prescription Use (Per 21CFR801.109) | <div> ✓ </div> | |-------------------------------------|--------------------------------------------| | | OR Over-The-Counter Use | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AMOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Angela Blackwell for MSR (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K042124 K042 . 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ ( IF NEEDED)