DEGOTZEN SYNCHRO

{0}------------------------------------------------ MAY 0-3 2002 <021245 Page 1 of 4 ## 510K Summary Statement for the de Gotzen "synchro" Intraoral Dental X-Ray System. ### General Information | Manufacturer: | de Gotzen S.r.l<br>Via Roma 45<br>21057 OLIGIATE OLONA (Varese) Italy | |-----------------------------|-----------------------------------------------------------------------------------------------------------------| | Establishment Registration: | | | Telephone: | (011) 39 0331 376760 | | Fax Line: | (011) 39 0331 376763 | | Contact Person: | Antonella GASPARRI, International Compliance Office | | Submitter: | The Gotzen Group, Inc., (dba) TG Group, Inc. Canada<br>3505 Laird Road, Unit #7<br>Mississauga, Ontario L5L 5Y7 | | Establishment Registration: | #9615032 & Health Canada Establishment: # 692 | | Telephone: | (877) 557-4888 (Watts Line) | | Fax Line: | (905) 820-3215 | | Contact Person: | Wayne Lebeau, President | | USA Office: | TG Group USA, LLC<br>30 Alden Terrace<br>Flanders, NJ 07836 | | Telephone: | (973) 927-3730 | | Fax Line: | (973) 927-4006 | | Contact Person: | Donald R. Hill, VP Sales & Marketing<br>USA FDA Liaison | | Summary Preparation Date: | January 24, 2002 | ## Name and Classification Device Name: de Gotzen synchro Intraoral Dental X-Ray System 90EHD - Unit, X-Ray, Extraoral with Timer Dental ## Primary Classification Name: Classification Panel: #### Predicate Devices The de Gotzen synchro Intraoral Dental x-ray System is substantially equivalent to the following previously cleared and currently marketed devices. Aztech 70 Gendex Gx770 Sirona Heliodent Vario Dent-x image X-70 Plus Belmont Belray 096 {1}------------------------------------------------ #### Product Description Page 2 of 4 The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components: - X-Ray tubehead and yoke . - . Articulating arm - Horizontal arm, standard length ● - Wall Mount - Electronic control timer (which may be mounted remotely) . - 8" and 12" Collimating cones . Optional components: - . Horizontal arm, short length - Horizontal arm, long length . - . Rectangular collimating cone The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds #### Intended Use: The de Gotzen synchro Intraoral Dental X-Ray System is an Extraoral source of x-rays for Intraoral images in dental radiography. #### Comparison of Technological Characteristics: Rationale for Substantial Equivalence. The de Gotzen synchro Intraoral Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features and therefore is Substantially Equivalent to the predicate devices listed in this summary. Table comparing performance of de Gotzen synchro with predicate devices: {2}------------------------------------------------ | Specifications | Aztech 70 | Gendex Gx770 | Sirona Heliodent Vario | Dent-x Image x-70 Plus | Belmont Belray 096 | de Gotzen synchro | |-----------------------------------------------------|-------------------------|--------------------------|--------------------------------------------------------|--------------------------------|-----------------------|-------------------------------------------------------| | Registration Number | K984524 | K935046 | K000672 | K000551 | K963699 | | | Line Requirements | 110V-120V 50Hz-<br>60Hz | 110V - 130V 60Hz | 100V/110V/120V, 11A<br>220V/230V/240V, 6A<br>50Hz/60Hz | 110V/220V, 50Hz/60Hz | 108V - 132V 50Hz.60Hz | 220V/230V/240V, 8A<br>110V - 120V 5.5A<br>50hZ - 60hZ | | Generator Type | AC | AC | AC Single Pulse | AC | AC | AC | | Tube Voltage | 65 kV | 70 kV | 70 kV | 70 kV | 70 kV | 70 kV | | Tube Current | 8 mA | 7 mA | 7mA | 8 mA | 10 mA | 8 mA | | Exposure Time Selection | 0.03 -3.0 Sec | 3-99 impulses (28 Steps) | 0.03 - 3.2 Sec | 0.08- 3.2 Sec | 0.02 -3.0 Sec | 0.08- 3.2 Sec. 17 Steps | | Focal Spot | 0.7 | 0.6mm | 0.8mm | 0.7 X 0.7 mm | 0.8 X 0.8mm | 0.7 X 0.7mm | | Focal Length | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in | 8in/12in | | Total Filtration in X-ray tube unit | Unknown | Unknown | >2 mm Al | >2.5 mm Al | >2.1 mm Al | >2.0 mm Al | | | | | | 28 mR/hr at 1m from focal spot | | Less than 2.5 mGy/h | | Leakage Radiation Compatiabel with Film and Digital | Yes | Yes | Yes | Yes | Yes | Yes | : Page 3 of 4 {3}------------------------------------------------ ### Conclusion Page 4 of 4 The deGotzen synchro Intraoral Dental X-Ray System was found to be /is substantially Equivalent to the predicate devices; the Aztech 70, Gendex Gx770, Siron Heliodent Vario, Dent-x image x-70, and Belmont Belray 096. The de Gotzen synchro shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of an eagle. #### Public Health Service **MAY 03 2002** Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 The Gotzen Group, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298 Re: K021245 Trade/Device Name: deGotzen synchro Intraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 18, 2002 Received: April 19, 2002 Dear Mr. Mosenkis: 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 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. 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. {5}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for a group. The logo consists of a large letter 'G' with the word 'Group' written to the right of it. The letter 'G' is stylized and appears to be partially obscured by a dark shape. # XI. INDICATIONS FOR USE STATEMENT Applicant: de Gotzen S.r.L. 510(k) Number (if known): k_02/245 Device Name: de Gotzen "synchro" Intraoral Dental X-Ray System Indications for Use: The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures. (Please do not write below this line – Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: underline;">_____</span> | |----------------------|----------------------------------------------------|----|----------------------|--------------------------------------------------------| | (Per 21 CFR 801.109) | | | | |  | (Division Sign-Off) | | |--------------------------------------|---------| | Division of Reproductive, Abdominal, | | | and Radiological Devices | | | 510(k) Number | K021245 | | (Division Sign-Off) | |------------------------------------------| | Division of Reproductive, Abdominal, ENT | | And Radiological Devices | 510K Number___________________________________________________________________________________________________________________________________________________________________