DOWN PAK

K070246 · Endo Twinn B.V. · EKM · Feb 16, 2007 · Dental

Device Facts

• Record ID: K070246
• Device Name: DOWN PAK
• Applicant: Endo Twinn B.V.
• Product Code: EKM · Dental
• Decision Date: Feb 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3850
• Device Class: Class 1
• Attributes: Therapeutic

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 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.

Indications for Use

Indicated for use by dentists and endodontists for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during root canal treatment.

Regulatory Classification

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)

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23 January 2007
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0F863.doc

revised
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## 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: [phone] Fax: [phone]
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

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### 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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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(