VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the text "K112305" written in a handwritten style at the top. Below the text is a logo for "Thunder Tiger". The logo consists of a circular emblem with an airplane silhouette inside, followed by the words "Thunder" and "Tiger" stacked on top of each other in a bold, stylized font. APR 1 7 2012 THUNDER TIGER CORP. NO.7, 6th ROAD INDUSTRY PARK. TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com # 1510(K) SUMMARY ## Vigor Series Low speed dental handpieces & Accessories - 1. Date Summary Prepared: August 10.2011 2. Submitter Information 510(k) Owner: THUNDER TIGER CORP. No.7, 6" Road, Industry Park, Taichung, 40755 Taiwan, ROC Contact Person: Jo S.C. Lee/QA Engineer jo@thundertiger.com - 3. Device Name Trade Name: Vigor Series Low speed dental handpieces & Accessories Common Name: Dental Handpiece Classification Name: Handpiece, air-powered, dental (21 CFR 872.4200, Product Code EFB) Handpiece, contra- and right-angle attachment, dental (21 CFR 872.4200, Product Code EGS) - 4. Predicate Device: E-TYPE CONTRA ANGLE NAC-E, (K962540) Surgical Contra-Angel Hanpieces Type WS-56E, WE-75E/KM, WS-92 (K011061) ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954) E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569) W&H AIR MOTOR A25 (K944711) ATHENA CONTRA ANGLE (K974670) #### 5. Device Description: The Vigor Series Low speed dental handpieces & Accessories are similar to other low-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are powered by either low speed air motor or electric micro-motor that are reusable and ergonomically shaped, and are provided without a fiber optic light system. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Thunder Tiger. The logo features a stylized image of an airplane inside of a circle. To the right of the circle is the text "Thunder Tiger" in a bold, sans-serif font. The Vigor C Low Speed Contra-Angle handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of these contra angle handpieces allows easy "snap-on" connection and removal from the motor. The contra-angle handpieces contain both chip air and water that help with removing debris from teeth cutting. The Vigor S Low Speed Straight handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of the Low Speed Straight handpiece allows easy connection and removal from the motor. It can be used with a variety of different burrs that conform to the specifications stated in ISO 1797-1. These nose-cones contain both chip air and water that help with removing debris from teeth cutting. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle and straight handpiece that are manufactured in accordance with ISO 7785-2. The locking mechanism of the motor allows easy connection and removal of any add-ons. The motor contains chip air and water that help with removing debris from teeth cutting. The devices are reused and can be sterilized by the steam autoclave method. - 6. Intended Use: The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting. ### 7. Performance: Vigor Series Low speed dental handpieces & Accessories have been tested to meet the requirement of ISO 7785-2 standard, ISO 13294 standard, ISO 9687 standard, ISO 9168 standard and FDA guidance "Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions". {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it, followed by the words "Thunder Tiger" stacked on top of each other. The words are written in a bold, sans-serif font. THUNDER TIGER CORP. NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com - Substantial Equivalency: 8. After analyzing the clinical testing data, it is the conclusion of substances of Vigor Series Low speed dental handpieces & Accessories are substantial equivalent to the predicate device in terms of its intended use, operating principles and functions. - 9. Discussion of Clinical Tests Performed: N/A - 10. Conclusion: The above descriptions coincide with the substantial equivalence made by E-TYPE CONTRA ANGLE NAC-E, (K962540), Surgical Contra-Angel Hanpieces Type WS-56E, WE-75E/KM, WS-92 (K011061), ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954), E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569), W&H AIR MOTOR A25 (K944711) and ATHENA CONTRA ANGLE (K974670) They are substantial equivalent to the predicate device in terms of its intended use, operating principles and functions. Therefore, it can be seen that Vigor Series Low speed dental handpieces & Accessories are both safe and effective for their intended use. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white. #### Public Health Service APR 1 7 2012 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Jo Lee Quality Assurance Engineer Thunder Tiger Corporation No. 7, 6th Road, Industry Park Taichung, China (Taiwan) 40755 Re: K112305 Trade/Device Name: Vigor Series Low Speed Dental Handpieces & Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EGS Dated: March 5, 2012 Received: March 6, 2012 Dear Ms. Lee: 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. {4}------------------------------------------------ #### Page 2 - Ms. Lee 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Ah tor 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 #### Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it, and the words "Thunder Tiger" written in bold letters to the right of the circle. The word "Thunder" is written above the word "Tiger". THUNDER TIGER CORP NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23591616 FAX : 886-4-23591902 E-mail: tt@thundertiger.com http://www.thundertiger.com ## Indications for Use 510(K) Number (If Known): Device Name: Vigor Series Low speed dental handpieces & Accessories Indications for Use: The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip air and water that help with removing debris from teeth cutting. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting. CAUTION: Federal (US)) law restricts the use of this device to licensed professionals AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ · (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) Swer Rusk (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K112305