(47 days)
The Engle Dental Systems Family of Dental Units are medical devices to be used by dentists, and hygienists in the procedures they perform. The Engle Dental Systems Family of Dental Units feature numerous attachments and suction instruments. The Engle Dental Systems Family of Dental Units utilize foot controls, assistant's arms, and were to taster to the hand pieces that 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.
Dental units
This 510(k) summary (K983285) for Engle Dental Systems Family of Dental Units does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a premarket notification to the FDA, asserting substantial equivalence to a predicate device. It includes:
- Applicant Information: Engle Dental Systems, Inc. Contact person Marvin Fox.
- Date Prepared: August 31, 1998.
- Trade Name: Engle Dental Systems Family of Dental Units.
- Unit Styles and Part Numbers: A table listing various delivery systems (AS-1, AS-2, EDS-1, ME-2, ME-2 Control Head Only, Micro II Miniature Control) and their respective part numbers. It notes that the differences in part numbers are primarily cosmetic and not technological.
- Common Name and Classification Name: Dental units, classified as Operative, dental (per 21 CFR 872.6640).
- FDA Response Letter: Dated November 4, 1998, stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
- Indications for Use: States that the Engle Dental Systems Family of Dental Units are medical devices to be used by dentists and hygienists in the procedures they perform, operating dental handpieces and featuring numerous attachments and suction instruments. It also explicitly states that the device is substantially equivalent to the 1400 XL Deluxe Dental Delivery System manufactured by Summit Dental Systems.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. This type of document (510(k) summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
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ល/១០០/អមប្រ
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 DeliverySystem | P070865, P070867, P070869, P070871, P070873, P070875,P070876, P050120 |
|---|---|
| AS-2 DeliverySystem | P070878, P070880, P070882, P070883, P070885, P050125 |
| EDS-1 DeliverySystem | P071900, P071902, P071904, P071906, P071908, P071934,P070886, P071935 |
| ME-2 DeliverySystem | P070840 through P070847, P070850 through P070857,P070860 through P070863, P070092, P070093, P050108,P050109, P050114,P050115 |
| ME-2 ControlHead Only | P050135, P050145, P071855 through P071862 |
| Micro IIMiniatureControl | 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.
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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
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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
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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.
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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 _
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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.