ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS

{0}------------------------------------------------ K983285 ល/១០០/អម​ប្រ 4 1998 NOV Image /page/0/Picture/2 description: The image is a logo for Engle Dental Systems. The logo is white text on a black background. The text is stacked in three lines, with "Engle" on the top line, "Dental" on the second line, and "Systems" on the third line. The text is in a bold, sans-serif font. P.O. 3ox 725 • Forest Grove, Oregon 97116 U.S.A. • 503/359-9390 • FAX: 503/357-7286 • 510 (k) SUMMARY Engle Dental Systems, Inc. 4115 24th Ave, Suite A P.O. Box 725 Forest Grove, ()R 97116 Registration Number: 3020989 Establishment ' l'ype: Manufacturer | Contact Person: | Marvin Fox | |-----------------|------------------------| | | Official Correspondent | | Tel: | (503) 359-9390 | | Fax: | (503) 357-7286 | Date Prepared: August 31, 1998 Trade Name: Engle Dental Systems Family of Dental Units ## Unit Style ## Various Engle Dental Part Numbers* | AS-1 Delivery<br>System | P070865, P070867, P070869, P070871, P070873, P070875,<br>P070876, P050120 | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | AS-2 Delivery<br>System | P070878, P070880, P070882, P070883, P070885, P050125 | | EDS-1 Delivery<br>System | P071900, P071902, P071904, P071906, P071908, P071934,<br>P070886, P071935 | | ME-2 Delivery<br>System | P070840 through P070847, P070850 through P070857,<br>P070860 through P070863, P070092, P070093, P050108,<br>P050109, P050114,<br>P050115 | | ME-2 Control<br>Head Only | P050135, P050145, P071855 through P071862 | | Micro II<br>Miniature<br>Control | P028101, P028115 | * Note: Please : ee matrix of parts (pages 19-20) for exact descriptions of each part number listed al ove. The different part numbers represent variations on the common control head sty es. For example, the P071900 is an EDS-1 Delivery System with an ASC 101 cuspic or, while the P071902 is an EDS-1 Delivery System with an ASC 102 cuspidor. The cifference between these two parts is the plastic housing on the cuspidor. The other part numbers contain similar design differences. Looking at the engineering drawings in Sec ions A, B, C, E, & M, it is clear that these differences are cosmetic and not technologic: I in nature. Common Name : Dental units Classification Name: Unit, operative, dental (per 21 CFR 872.6640) Sec. 872.6640. Dental operative unit and accessories. Image /page/0/Picture/14 description: The image shows a stylized drawing of the letters 'P' and 'I'. The letters are drawn in a bold, somewhat abstract style, with thick lines forming their shapes. The 'P' is positioned above and slightly to the left of the 'I', and both letters are tilted at an angle, giving the image a dynamic and informal feel. The drawing is simple and monochromatic, with no shading or additional details. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 4 1998 NOV Mr. Marvin Fox Official Correspondent Engle Dental Systems, Incorporated 4115 24th Avenue, Suite A P.O. Box 725 97116 Forest Grove, Orlando Re : K983285 Engle Dental Family of Delivery Systems Trade Name: Requlatory Class: I Product Code: EIA Dated: August 31, 1998 Received: September 18, 1998 Dear Mr. Fox: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 {2}------------------------------------------------ Page 2 - Mr. Fox through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (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" (CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamajp.html". Sincerely yours Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ﺎ، {3}------------------------------------------------ Indications for Use 510(k) Number (if known): K983285 Device Name: Demal Delivery System Indications for Use: The Engle Dental Systems Family of Dental Units are medical devices to be used by dentists, the hands of the bands of the bands of the bands of the bands of the bands of the The Engle Dental Systems Family of Demal Dilletines and were to taster to the hand pieces that and bygienists in the procedures they perform of the sates on one one one one operate demal handpock the dentists use in the procedures they periodi on the stanges as Upits feature numerous attachments and su fion instruments. The Eligie Domar Dyschall foot controls, assistant's arms. The Engle Dental : lystems Family of Dental Units is substantially equivalent to the 1400 XI. Deuxe Dental Systems is The Engle Dental : hystems Family of Dental Unit Is Suscenas in Ft. Lauderale, FL. Ental Systems is Delivery System in anufactured by Summit Demail Systems in F. Landanalisy of Same Shares of the parts related to the construction ar d maintenance of the dental units. ## (PLEASE DO NOT WRITE BELOW THIS LINE) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 80 1.109) OR Over-The-Counter Use Snser Russo (Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Infection Football Hospital Devices 510(k) Number _ ||