CLEAN 'N' OIL

• K Number: K022264
• Device Name: CLEAN 'N' OIL
• Manufacturer: SVENSKA DENTAL INSTRUMENTS AB
• Date Cleared: 2002-10-02 ( 82 days)
• Product Code: EGS
• Regulation Number: 872.4200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Clean 'n' Oil."

This type of letter primarily indicates that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. It does not contain information about specific performance acceptance criteria or detailed study results.

The document mentions:

• Trade/Device Name: Clean 'n' Oil
• Regulation Number: 872.4200
• Regulation Name: Dental Handpiece and Accessories
• Regulatory Class: I
• Product Code: EGS
• Indications For Use: "Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors."

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a more detailed 510(k) summary that includes performance testing. The current document is a regulatory approval letter based on substantial equivalence, and it does not contain the information you are looking for regarding acceptance criteria or detailed study data.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 2 2002

Ms. Emma Bergquist Product and Quality Co-Ordinator Svenska Dental Instruments AB Finvids väg 8 P.O. Box 723 SE-194 27 Upplands Väsby SWEDEN

Re: K022264

Trade/Device Name: Clean 'n' Oil Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: July 1, 2002 Received: July 12, 2002

Dear Ms. Bergquist:

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 vour 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.

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Page 2 – Ms. Bergquist

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.

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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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5 10(k) | Jumbe :

K022264

Clean'n'Oil

[Jevice Name:

Indicati ans Fo · Use:

Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors.

(PLE ASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K033064

Pre :criptio \ Use: _ (Pe 21CFIR 801.109)

Over -the-Counter Use: __

(Optional format 1-2-96)

Svonska Dental Instrument AB

P.C. Box 723 SE 194 27 Upplands Väsby SW EDEN

Phone No [phone] [phone] Direct line E-mail order and information E-mail Web site

OR

[phone] Telefax No VAT-No SE556013882701 [e-mail] [e-mail] www.sdidirecta.com

Regulation Number and Section

§ 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.