(39 days)
The irrigation tubing set is an accessory to dental surgical units. The irrigation tubing set is used to supply treatment fluid from the reservoir to the handpiece via a pump.
elcoMED SA-200, elcoMED SA-200 C and implantMED SI-95 consist of fa elcoMED SA-200, elcoMED OA 200 control and a controller. They are designed for use in dental surgery. Optimum irrigation of the treatment site is an important factor for successful Oplinium imgation of the treatment one 10 all of all and its reservoir via a pump to the motor / handpiece.
The provided text describes a 510(k) summary for an irrigation tubing set and Y-switch. It does not contain information about acceptance criteria, detailed device performance metrics beyond a statement of substantial equivalence, or any study details that would typically be associated with AI/ML device testing (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on intended use and technological characteristics rather than detailed performance study results against specific acceptance criteria.
{0}------------------------------------------------
| JUN - 7 2004 | 510(k) SUMMARY | ||
|---|---|---|---|
| Submitted by: | W & H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustria | K04112 | |
| Contact person: | Ralf BendaTel.: +43-6274-6236-193Fax: +43-6274-6236-234 | ||
| Date of Preparation: | 21/04/2004 | ||
| Device name: | Accessory for: | elcoMED SA-200elcoMED SA-200 CimplantMED SI-95 | |
| Common name: | Irrigation tubing set and Y-switch | ||
| Classification name: | Controller, foot, handpiece and cord | ||
| Predicate device: | Irrigation tubings, which were part (accessory) ofthe submissions of the dental surgical unitselcoMED SA-200, elcoMED SA-200 C andimplantMED |
Device Description:
elcoMED SA-200, elcoMED SA-200 C and implantMED SI-95 consist of fa elcoMED SA-200, elcoMED OA 200 control and a controller. They are designed for use in dental surgery.
use in dental surgery.
Optimum irrigation of the treatment site is an important factor for successful Oplinium imgation of the treatment one 10 all of all and its reservoir via a pump to the motor / handpiece.
Intended use:
- Supply of the fluid from the reservoir via a drip chamber to the pump, ।
- Passage of the fluid through the pump and r
- Supply of the fluid to the handpiece. ।
Technological Characteristics:
The irrigation tubing set is the update of the previous tubings. It is a single use The inigation tubing sec is the upacts of the procement prior to use. It is delivered sterile.
Substantial equivalence:
The irrigation tubing sets and the predicate device share the same indication for use and similar characteristics.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 resembling three overlapping lines or stripes, which is a common element in the department's branding.
Public Health Service
JUN - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ralf Benda W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Strasse 53 A- 5111 Buermoos AUSTRIA
Re: K041124
Trade/Device Name: Irrigation Tubing Set 2.2M and 3.8M Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: April 21, 2004 Received: April 29, 2004
Dear Mr. Benda:
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.
{2}------------------------------------------------
Page 2 - Mr. Benda
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticase be advisod that I Da determination that your device complies with other requirements Incall that 1 DA mas made a actes and regulations administered by other Federal agencies. of the Act of any I oderal barrequirements, including, but not limited to: registration r ou intist comply will and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RT rat 007), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sion 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) This letter will anow your even substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific at 700 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 may obtain other general 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,
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Indications for Use: Irrigation tubing set and y-swich The irrigation tubing set is an accessory to dental surgical units. surgical units.
The irrigation tubing set is used to supply treatment The frigation tabing on the reservoir to the handpiece via a pump
Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
04/126 510(k) Number:_
Page 1 of 1
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.