SONATA MICRO HYBRID COMPOSITE

{0}------------------------------------------------ ## APR 2 2 2002 K020333 #### 510(K) SUMMARY 21.0 Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration. Sonata Micro Hybrid Composite is substantially equivalent to Conquest Crystal, K932154 and other dental restorative resin composites on the market. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES APR 2 2 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492 Re: K020555 Trade/Device Name: Sonata Micro Hybrid Composite Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 19, 2002 Received: February 20, 2002 #### Dear Ms. Tenero: 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 vour 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. 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. {2}------------------------------------------------ #### Page 2 -- Ms. Annmarie Tenero You must comply with all the Act's requirements, including, but not limited to: registration I ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rat 807), assimm (QS) regulation (21 CFR Part 820); and if requirements as set form in are quality ijon 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 11113 letter will and w yours of substantial equivalence of your device 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 IT you desire specific act res 10.1 for in vitro diagnostic devices), please contact the and additionally 21 CF1 (301) 594-4613. Additionally, for questions on the promotion and Office of Colliphance wice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Act may be vealined 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, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### 5.0 INDICATION FOR USE STATEMENT # 5100) NUMBER (IF KNOWN): ### DEVICE NAME: Sonata Micro Hybrid Composite #### INDICATION FOR USE: Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration. #### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.) Image /page/3/Figure/6 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use (Per 21 CFR 801.109)" and "Over-The-Counter-Use (Optional Format 1-2-96)". The prescription use option has a checkmark next to it. The number 5.0 is written on the right side of the form, and the signature of "Susan Runo" is at the bottom, along with the text "(Division Sign-Off) Division of Dental, Infection Control". and General Hospital Devices Jeneric/Pentron, Inc. 510K Submission - Sonata Micro Hybrid Composite 10(k) Number _________________________________________________________________________________________________________________