← Product Code [EKM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM) · K070246 # DOWN PAK (K070246) _Endo Twinn B.V. · EKM · Feb 16, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K070246 ## Device Facts - **Applicant:** Endo Twinn B.V. - **Product Code:** [EKM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM.md) - **Decision Date:** Feb 16, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 872.3850 - **Device Class:** Class 1 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The intended use of the dental instrument heater -- the Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists. ## Device Story Down Pak is a battery-operated, cordless dental instrument heater; provides continuous heat and low-frequency vibration to a dental tip. Used by dentists and endodontists during root canal procedures to soften, spread, and compact gutta percha and cut obturator handles. Operated via a single button on the handpiece; rechargeable via a dedicated base. Tips are autoclavable; handpiece is disinfectable with 80% alcohol. Device maintains a preset temperature automatically based on the attached tip. Benefits include consistent thermal and vibrational application for improved root canal obturation. ## Clinical Evidence Bench testing only. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 14971 (risk management), and ISO 10993-5/10 (biocompatibility) was demonstrated. ## Technological Characteristics Battery-operated cordless handpiece; heating and vibration mechanism; autoclavable tips; rechargeable base. Materials: plastic user interface. Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-5, ISO 10993-10. Disinfection: 80% alcohol. ## Regulatory Identification Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. ## Predicate Devices - Endo Twinn ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a close-up of a logo or label with the word "Twin" prominently displayed. The text is in a sans-serif font and appears to be white against a dark background. The logo is enclosed in a rounded rectangle, giving it a clean and modern look. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution photograph. 1 23 January 2007 FV 0F863.doc revised approved signed ## 510(k) Summarv K. 70246 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. - A. Name, Address, Phone and Fax number of the Applicant EndoTwinn B.V. Danzigerkade 17 1013 AP Amsterdam The Netherlands Telephone: +31 20 486 7571 Fax: +31 20 486 3280 FEB 1 6 2007 - ങ്ക് Contact Person Frank Verhoeven - C. Date Prepared 23 January 2007 #### D. Device Name Trade Name: Down Pak Classification Name: Gutta Percha Prosthetic Device, Class 1 Regulation Number and Product Code: 872.3B50, EKM Classification Panel: Dental ### E. Device Description The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol. ### デ. Intended Use The intended use of the dental instrument heater -- the Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percial (andring softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treament The device may only be operated by dentists and endodentists. ### G. Substantial Equivalence The dental instrument heater the Down Pak is a mod fied version of Endo Twinn and has the same technological characteristics. The modification is to change the plastic material of the user interface. ### H. Device Testing Results The Down Pak complies with the requirements of recognized consensus standards - IEC 60601-1:1988 +A1. A2 - - IEC 60601-1-2: 2001 - - ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ISO 14971:2000 + A1 - ---ISO 10993-5:1999 - -ISO 10993-10:2002 {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. F.M. Verhoeven Chief Operational Official EndoTwinn B.V. Danzigerkade 17, Amsterdam, Netherlands 1013 AP FEB ] & 2007 Re: K070246 Trade/Device Name: Down Pak Regulation Number: 872.3850 Regulation Name: Gutta Percha Regulatory Class: I Product Code: EKM Dated: January 23, 2007 Received: January 25, 2007 Dear Mr. Verhoeven: 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. {2}------------------------------------------------ Page 2 - Mr. Verhoeven 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. 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 510(k) Number (if known): K0610346 Device Name: Down Pak Indications for Use: The intended use of the dental instrument heater - The Down Pak - is to provide The intended use of the dontal instrument. The tip of a dental instrument. The Down Pak is continuous ficul and or vibration at a cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists. Prescription Use (Part 21 CFR 801 Subpart D) ANI »/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kein Morley for 1958 K07024( --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K070246](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K070246) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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