CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,

{0}------------------------------------------------ OCT - 1 2003 K022505 510(k) Notification July 23, 2002 ## SECTION 10 ## 510(k) Summary Submitter: NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland Contact Person: Benno Frei Technical Director, New Product Development Phone 0041 71 845 35 35 0041 71 845 35 36 Fax Date Summary Prepared: July 23, 2002 Device Name: Trade Name == Common Name Contra-Angle Attachments Dental Handpiece, Contra- and Right-Angle Attachments Dental Classification Name (per 21 CFR section 872.4200) Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed: | Company: | W & H Dentalwerk Buermoos GmbH | |---------------|---------------------------------------------| | Device: | Surgical Contra-Angel Handpiece Attachments | | 510(k) : | K011061 | | Date Cleared: | June 21, 2001 | {1}------------------------------------------------ 510(k) Notification July 23, 2002 | Company: | W & H Dentalwerk Buermoos GmbH | |---------------|---------------------------------------------| | Device: | Surgical Contra-Angel Handpiece Attachments | | 510(k) : | K984508 | | Date Cleared: | June 25, 1999 | | Company: | NSK, INC | | Device: | E-Type Contra-Angle | | 510(k) : | K962540 | | Date Cleared: | September 12, 1996 | | Company: | NSK, INC | | Device: | E-Type Speed Increaser Contra-Angle | | 510(k) : | K972569 | | Date Cleared: | October 08, 1997 | ## Device Description: All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece. For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964. The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1. Intended us of the Devices: Indications are very widespread in the field of Dentistry. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device: The NOUVAG Contra-Angle Attachments Dental are substantially equivalent to other legally marketed evices in the United States. The NOUVAG Contra-Angle Attachments Dental functions in a manner similar and are intended for the same use as the Surgical Contra-Angel Handpiece Attachments designed by W & H Dentalwerk Buermoos GmbH and NSK NAKANISHI INC. {2}------------------------------------------------ 510(k) Notification July 23, 2002 | Characteristics | NOUVAG<br>Contra-Angle Attachments Dental | Predicate Device W & H<br>Surgical Contra-Angel Handpieces Types | Predicate Device NSK<br>E-Type Contra-Angle | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Indications for use | Indications are very widespread in the<br>field of implantology and surgery | Indications are very widespread in the<br>field of implantology and surgery | Indications are very widespread in the field<br>of implantology and surgery | | Target population | No restriction | No restriction | No restriction | | Design | Contra-angle | Contra-angle | Contra-angle | | Materials | Alloy coated with pure chromium | Stainless steel | Stainless steel | | Performance | ISO 7785-2<br>ISO 3964 | ISO 7785-2<br>ISO 3964 | ISO 7785-2<br>ISO 3964 | | Sterility | Sterility by user / 134°C | Sterility by user / 134°C | Sterility by user / 134°C | | Biocompatibility | Acc. ISO 10993-1 / -5 / -12 | Biocompatible material | Biocompatible material | | Mechanical safety | ISO 7785-2 | ISO 7785-2 | ISO 7785-2 | | Human factors | Gear ratio marked on the device | Gear ratio marked on the device<br>Color coding | Gear ratio marked on the device<br>Color coding | | Compatibility with<br>other devices | Coupling dimensions acc. ISO 3964<br>For burs with shanks acc to ISO 1797<br>(2.35 mm and 1.6 mm)<br>Push button system and Latch type | Coupling dimensions acc. ISO 3964<br>For burs with shanks acc to ISO 1797<br>(2.35 mm and 1.6 mm)<br>Push button system | Coupling dimensions acc. ISO 3964<br>For burs with shanks acc to ISO 1797<br>(2.35 mm and 1.6 mm)<br>Latch Type | | Where used | Dental | Dental | Dental | # TABLE 1 TECHNOLOGICAL COMPARISON Image /page/2/Picture/4 description: The image shows the text "10-3" in a simple, sans-serif font. The number "10" is followed by a hyphen and then the number "3". The text is black and appears against a white background. The text is centered in the image. {3}------------------------------------------------ 510(k) Notification July 23, 2002 Brief summary of nonclinical tests and results: The NOUVAG Contra-Angle Attachments Dental have been designed and tested to applicable safety standards. The NOUVAG Contra-Angle Attachments Dental do not raise any new issues of safety, effectiveness, or performance of the product. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 1 2003 NOUVAG AG C/O Mr. Erich Forster INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf, SWITZERLAND Re: K022505 Trade/Device Name: Contra-Angle Attachments Dental Regulation Number: 872.4200 Regulation Name: Accessory to Dental Handpiece Regulatory Class: I Product Code: EGS Dated: June 30, 2003 Received: July 3, 2003 Dear Mr. Forster: 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. {5}------------------------------------------------ ## Page 2 - Mr. Forster 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 (OS) 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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html Sincerely yours, Suan Ruisnro Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ K022505 510(k) Notification November 29, 2002 510(k) Number (if known): K022505 Device Name: Contra- Angle Attachments Dental Types: 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, 5069, 5070, 5071, 5075, 5076, 5081 Indications for Use: Indications are widespread in the field of Surgery, Implantology and Endodontic treatment. - Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075 - . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076 - . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE)  (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number: | kd22505 | |----------------|---------| |----------------|---------| (Optional Format 3-10-98)