DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING

{0}------------------------------------------------ Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego, CA 92111 4 مراهم م ・、 Image /page/0/Picture/1 description: The image shows the word "AEROBINE" in bold, sans-serif font. Above and below the word are curved lines that form a circle around the word. The curved lines are thicker than the letters in the word. Tol) 858–277–1700 Fax) 858–571–7383 www.aerobine.com info@aerobine.com 163 # 5 510(k) SUMMARY K101717 AUG 2 0 2010 ## Aerobine Line of Dental Handpieces | Submitted by: | Aerobine, Inc.<br>7670 Opportunity Rd. Suite 100<br>San Diego, CA 92111 | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Yong W. Kim, President<br>Tel: 858-277-1700<br>Cell: 858-382-8526<br>Fax: 858-571-7383 email: ywkim@aerobine.com | | Date of Summary: | March 9, 2010 | | Common name: | Air-powered Dental Handpiece | | Device name: | Aerobine Line of Dental Handpieces: Karam STD, Karam Mini, Karam ECN,<br>AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling,<br>Karam 2A coupling | | Classification: | Dental Handpiece and Accessories<br>Class I Medical Device: 21 CFR 872.4200<br>Product Code: EFB<br>Panel 72 | | Predicate Devices: | JINDELL Highspeed Air Turbine Handpiece (K062740)<br>Product Code: EFB<br>IMPACT Air 45 Handpiece for Periodontal Use (K972376)<br>Product Code: EFB | {1}------------------------------------------------ Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego CA 92111 K101717 Tel) 858-277-1700 Fax) 858-571-7383 #### 5.1 Device Description The devices are an air-powered dental handpieces intended for use with a friction-grip bur that conforms to ISO 1797-1 standard. Recommended air pressure is 29 ~ 36 psig (gage pressure) to produce high-speed bur rotation ranging between 380,000 and 450,000 RPM. Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are straight-headed. Karam45 and Dexor45 models are designed with a 45-degree back angle. The devices include a water line that directs water mist/jet to the cutting area for cooling and irrigation. #### 5.2 Indications for use Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling. Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. #### 5.3 Description of device design Aerobine line of handpieces employs a cartridge type air turbine with a common core design across the product line. All models employ a friction-grip push button chuck, a drive air line, a discharge air egress line, a water delivery line to supply cooling water. With the exception of Karam ECN, all models can be used with either Karam 4B or Karam 2A coupling. Karam ECN connects directly to Type A or Type B hose connectors without a coupling. Comparison of device technological characteristics relative to predicate devices is made in Table 1. #### Conclusions from Technical Comparisons with predicate devices 5.4 Based on technological profile comparisons (Table 1) and engineering analysis results obtained in support of the sterilization validation effort (section 14), we conclude: - Aerobine Handpieces, Karam STD/Mini/ECN, AeroBreeze STD/Mini are substantially equivalent to the predicate device (K062740) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics. - Aerobine Handpieces, Karam45, Dexor45 are substantially equivalent to the predicate device -(K972376) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics. {2}------------------------------------------------ K101717 AEROBINE 3073 kerobine, Inc. 1670 Opportunity Rd. Suite 100 San Diego, CA 92111 ﺮ ﮐ Tel) 858-277-1700 Fax) 858-571-7383 www.aerobine.com info@aerobine.com - Aerobine Line of Dental Handpieces (Model: Karam STD, Karam Mini, Karam ECN, -AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, Karam 2A coupling) are both safe and effective for their intended use. ### Table 1 Technological Characteristics Comparisons | Technological<br>Characteristics | Karam<br>STD/Mini/ECN,<br>AeroBreeze STD/Mini | Comparison<br>to Predicate<br>Device<br>(K062740) | Karam45. Dexor45 | Comparison to<br>Predicate Device<br>(K972376) | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Indication For<br>Use | For restoration and<br>cavity preparation | Identical | For surgical procedures<br>such as 3rd molar removal | Identical | | Energy source | Compressed air | Identical | Compressed air | Identical | | Design | Cartridge type turbine,<br>friction-grip push-button<br>chuck, cooling water<br>delivery system,<br>couplings | Identical | Cartridge type turbine,<br>friction-grip push-button<br>chuck, cooling water<br>delivery system,<br>couplings, rear air bleed<br>for improved infection<br>control | Identical Except:<br>non-catridge type<br>turbine | | Minimum<br>Performance<br>requirements | Speed range, stall<br>torque, cooling water<br>flow rate, noise level,<br>bur extraction force,<br>eccentricity | Identical | Speed range, stall torque,<br>cooling water flow rate,<br>noise level, bur extraction<br>force, eccentricity | Identical | | Standards met | EN ISO 7785-1<br>ISO 9168<br>ISO 1797-1 | Identical | EN ISO 7785-1<br>ISO 9168<br>ISO 1797-1 | Identical | | Composition of<br>Materials | Stainless steel,<br>aluminum alloy, copper<br>alloy, chrome plating,<br>nickel plating, elastomer | Identical | Stainless steel, aluminum<br>alloy, copper alloy,<br>chrome plating, nickel<br>plating, elastomer | Identical | | Biocompatibility | Constructed from usual<br>and common materials<br>known to the industry | Identical | Constructed from usual<br>and common materials<br>known to the industry | Identical | | Sterility | Autoclave up to 135°C<br>15 minutes at 134 °C | Unknown | Autoclave up to 135°C<br>15 minutes at 134 °C | Autoclave up to<br>135°C<br>20 minutes at 135°C | | Electrical Safety | No electrical connection | Identical | No electrical connection | Optional fiber-optic | | Chemical Safety | Used corrosion-resistant<br>materials, free of<br>chemical hazard | Identical | Used corrosion-resistant<br>materials, free of<br>chemical hazard | Identical | {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes stacked vertically. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Aerobine, Incorporated C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087 AUG 2 0 2010 Re: K101717 Trade/Device Name: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, and Karam 2A coupling Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: August 5, 2010 Received: August 6, 2010 Dear Ms. Wilkerson: 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. Wilkerson 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 vours, Nh 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 Enclosure {5}------------------------------------------------ Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego, CA 92111 K101717 AEROBINE Tel) 858-277-1700 Fax) 858-571-7383 .aerobine.com info@aerobine.com #### Indications for Use 4 510(k) Number (if known): Device Names: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45. Karam 4B coupling, and Karam 2A coupling ### Indications For Use: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling. Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. | Prescription Use | X AND/OR Over-The-Counter 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)(Division Sign-Off) | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |---------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Page 1 of 1 | | | 4-1 | | |-----|-----------------| | | Number: K101717 |