CARE3 PLUS

K081811 · Nakanishi, Inc. · EFB · Jan 21, 2009 · Dental

Device Facts

• Record ID: K081811
• Device Name: CARE3 PLUS
• Applicant: Nakanishi, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments. NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized.

Device Story

Care3 Plus is a maintenance device for rotating dental and surgical instruments. It performs internal cleaning by purging old lubricant from instruments. The device is intended for use by licensed dental professionals in a clinical setting. It must be used on pre-cleaned instruments before they undergo sterilization. The device facilitates instrument maintenance, ensuring proper function and hygiene.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental handpiece maintenance device for internal cleaning and lubrication. Operates as an accessory to rotating dental and surgical instruments. Class I device (21 CFR 872.4200).

Indications for Use

Indicated for internal cleaning and purging of old lubricant from rotating dental and surgical instruments. Restricted to use by licensed professionals on pre-cleaned instruments prior to sterilization.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nakanishi Incorporated C/O Mr Keith A Barritt Fish & Richardson P C 1425 K Street, North West, 11th Floor Washington, DC 20005

JAN 21 2009

K081811 Trade/Device Name Care3 Plus Regulation Number 21 CFR 872 4200 Regulation Name Dental Handpiece and Accessories Regulatory Class I Product Code EFB Dated December 19, 2008 Received December 22, 2008

Dear Mi Barntt

Re

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

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Page 2 - Mi Barritt

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 himited 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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premailed notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometice's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act 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 gov/cdrh/industry/support/index html

Sincerely yours,

Aristoteles de Anima fer

Ginette Y Michaud, M D Acting Director DIVISION of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) _

Device Name Care3 Plus

Indications For Use

Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments

NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized

Nakanishi proposes that Care3 Plus carry the following label

CAUTION Federal (US) law restricts the use of this device to licensed professionals

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Kuase

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

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510(k) Number KCS 181