TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for "TEK USA". The word "TEK" is in large, bold, sans-serif font on the top left. To the right of "TEK" is a star with stripes and stars on it, resembling the American flag. To the right of the star is the word "USA" in a similar font to "TEK". JUN 2 9 2012 ## 510(k) Summary "This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." K120218 "The assigned 510(k) number is: (applicant leave blank) ## Company: Submitter's name: Submitter's address: 1635 SW 15th St Pompano Beach, FL 33069 954-943-0565 · David White Palm Beach Dental Supply d/b/a TEK USA Phone number: 954-941-7137 Name of contact: Fax number: ## Proprietary/Trade Name: Device name; Air powered dental handpiece Proprietary/Trade name: TEK USA Airdriven LED Handpiece with Integrated E- generator Common name: Dental handpiece #### Classification: Classification name: Dental Handpiece and Accessories Device Classification : -Regulation Number: 21CFR 872.4200 Panel: Dental Product Code: EFB ("Handpiece, Airpowered, Dental") {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo with the text "TEK" on the top left, a star in the middle, and "USA" on the bottom right. The star is filled with a pattern of stripes and stars, resembling the American flag. The text and star are in bold, black font, and the background is white. The image quality is somewhat degraded, with some pixelation and artifacts around the edges of the text and star. #### Predicate Device: Predicate 510(k): K082716 Trade name: W&H Alegra Air-Driven Highspeed Handpiece Product Code: EFB ("Handpiece, Airpowered, Dental") · ## Device Description: Device Description: TEK USA Airdriven LED Handpiece with Integrated E- generator #### Intended Use: Device Intended Use: The TEK USA Airdriven LED Handpiece with Integrated E-Generator is indicated for use by a trained dental professional authorized in the practice of general dentistry. These dental handpiece devices are available in both high and low speed and are designed for removing carous material, reducing hard tooth structure, cavity preparation, finishing tooth preparations/restorations, polishing teeth and other procedures that are considered within the space of dental prophylaxis. ### Technological Characteristics: " The TEK USA Airdriven LED Handpiece with Integrated E- generator is compared directly to the predicate device: Substantial Equivalence Comparison Summary Table Predicate Device & 510(k) Number: W&H Alegra Air-Driven Highspeed Handpiece (k082716) | Predicate device promotional materials are attached in section 11.0 | | |---------------------------------------------------------------------|-------------------| | Technological Characteristics | Comparison Result | | Indication for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Similar | | Performance | Similar | | Sterility | Similar | | Biocompatibility | Similar | | Mechanical safety | Similar | | Chemical Safety | Similar | | Anatomical sites | Similar | | Human factors | Similar | | Energy used and/or delivered | Similar | | Compatibility with environment/other devices | Similar | | Where used | Identical | | Standards met | Similar | | Electrical safety | Similar | | Thermal safety | Not applicable | **(V)** {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a logo with the text "TEK" on the left and "USA" on the right. In the center of the logo is a star with stripes, resembling the American flag. The text and the star are stylized with a slightly distressed or textured appearance, giving the logo a rugged or vintage feel. The overall design is simple and patriotic, likely representing a company or organization with ties to the United States. | | Company Control A. A. J. A. | And Annual distribution All A | 10.000<br>College on come a come a come of | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Note: As noted in the above Substantial Equivalence Comparison Summary Table similarity with sterility is based on use of an FDA cleared table top autoclave sterilizer as detailed in K021504. The parameters for use with this device are as follows: | Recommended Use | Sterilization Time | Sterilization Temp | Drying Time | |------------------------------------------|--------------------|--------------------|-------------| | Unwrapped handpiece | 3.5 mins | 134° C (273°F) | 0 mins | | Wrapped handpiece<br>(mylar/tyvek pouch) | 8 mins | 134° C (273°F) | 20 mins | #### Substantial equivalence: The TEK USA Airdriven LED Handpiece with Integrated E- generator successfully meets the following international standards: - ISO 13485: 2003 + AC:2007: "the international standard for Medical devices Quality � management systems - Reguirements for regulatory purposes." Version 2007 - ISO 1797-1: "Dental rotary instruments. Shanks. Shanks made of metals" Version 1995 - ISO 9168: "Specification for screw gauge limits and tolerances. Gauges for ISO metric screw threads" Version 1968 - EU Medical Devices Directive, ref 93/42/EEC (incl 2007/47/EC): Version 2007 . - /SO 13402 : "Surgical and dental hand instruments. Determination of resistance against . autoclaving, corrosion and thermal exposure" Version 1995 - ISO 14971: "Medical device risk management" Version 2007 - ISO 10993-1: "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" Version 2009 - ISO 10993-5: "Biological evaluation of medical devices: Evaluation and testing within a . risk management process" Version 1999 - ISO 10993-10: "Biological evaluation of medical devices: Tests for irritation and skin sensitization" Version 2010 - EN 1041: "Information supplied by manufactures of medical devices" - ISO 9687: "Dental equipment. Graphical symbols" Version 1993 - EN 980: "Graphical symbols for use in the labeling of medical devices" Version 1997 #### Clinical Data: Clinical data is not needed for most dental handpieces cleared by the 510(k) process. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with the text "TEK USA". The word "TEK" is positioned on the left side of the image, and the word "USA" is on the right side. In the center of the image is a star with stripes, resembling the American flag. #### Conclusions: It can be concluded that the TEK USA Airdriven LED Handpiece with Integrated E- generator meets the ASTM or equivalent (ISO) standards such that the device demonstrates substantial equivalence to the W&H Alegra Air-Driven Highspeed Handpiece (k082716) predicate device. ・ . . . · . . {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest the shape of the bird's body and wings. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Palm Beach Dental Supply d/b/a TEK USA C/O Mr. Michael Calhoun Calhoun and Associates 2700 NE 24th Street Pompano Beach, Florida 33069 JUN 2 9 2012 Re: K120218 Trade/Device Name: TEK USA Airdriven LED Handpiece with Integrated E-Generator Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 7, 2012 Received: June 13, 2012 Dear Mr. Calhoun: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {5}------------------------------------------------ ## Page 2- Mr. Calhoun 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. ph for, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K120218 Device Name: TEK USA Airdriven LED handpiece with Integrated E-Generator Indications For Use: The TEK USA Airdriven LED handpiece with Integrated E-Generator is indicated for use by a trained dental professional authorized in the practice of general dentistry. These dental handpiece devices are available in both high and low speed and are designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations/restorations, polishing teeth and other procedures that are considered within the space of dental prophylaxis. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) C. R Steen . Jivision Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K120218