OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700

{0}------------------------------------------------ | II. | DEC - 1 2004<br>510(K) Summary | K042828 | |-----|--------------------------------|-------------------------------------------------------------------------------------------------------------| | | Submitted by: | Young OS LLC<br>Obtura Spartan<br>1663 Fenton Business Park Ct.<br>Fenton, Missouri 63026<br>(636) 343-8300 | | | Contact Person: | Stephen W. Conger, Jr. | | | Date Prepared: | September 22, 2004 | | | Proprietary Name: | Obtura | | | Common name: | Obtura Heated Gutta Percha System | | | Classification Name: | Instrument, Filling, Plastic, Dental | | | Predicate Device: | Heated Gutta Percha System<br>510(k) #K832654<br>and/or<br>Elements Obturation Unit<br>510(k) #K031664 | Description of the Device: The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654. Intended Use of the Device: The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal. ## Technological Characteristics: This device has the same technological characteristics and the predicate Obtura device and is operated by the user in the same fashion. The electronics have been update to comply with current standards and regulations, and the materials and design were selected for better aesthetics and asepsis. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 1 2004 Mr. Stephen W. Conger Executive Vice President Young OS LLC 1663 Fenton Business Park Court Fenton, Missouri 63026 Re: K042828 K042020 Trade/Device Name: Obtura Heated Gutta Percha System Regulation Number: 872.4562 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EKR Dated: October 7, 2004 Received: October 12, 2004 Dear Mr. Conger: We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becalent of 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 Interstate commerce prior to ria, 20, 1970, 1970, 1970, 1970, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999 Amelluments, or to devroos that natio e Act (Act) that do not require approval of a premarket the Federal Pood, Drug, und Cosment 1 to e-forapproval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the Pict. "The gains 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 If your device is classified (see above) into exactives. Existing major regulations affecting (PMA), if may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Conger Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled of a base our device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and reguirements, including, but not limited to: registration You must comply with an the Pice oreq 21 CFR Part 801); good manufacturing practice and listing (21 CFR I art 607), laboling (21 CFR Pat 82), and if a requirements as set forth in the quality systems (QS) regulation (21 CFR Partity of the A requirements as set form in the quality systems (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) This letter will anow you to begin marieting your substantial equivalence of your device to a premarket nonication. "The PDA miams of cassification 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 advice for your 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 may obtain other general miremis, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Puarez 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 {3}------------------------------------------------ ## Indications For Use Statement VI. 510(K) Number: | 042828 Device Name: Obtura Heated Gutta Percha System Indications for Use: The Obtura is intended for use by professionally qualified indications for OSC. The Obtard to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_X (Per 21 CFR §801 Subpart D) OR Over-The Counter Use (21 CFR 807 Subpart C Cink D. thmer for MSR (Division Sıgn-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number _ LD42823