MODIFICATION TO KAVO QUATTROCARE

K071288 · Sybron Dental Specialties, Inc. · EBF · Jul 19, 2007 · Dental

Device Facts

• Record ID: K071288
• Device Name: MODIFICATION TO KAVO QUATTROCARE
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Jul 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

Device Story

KaVo QUATTROcare Modified is a dental handpiece maintenance unit. It utilizes an aerosol-based lubricant/cleaner housed in a specialized spray can. The device performs internal cleaning and purging of old lubricant from rotating dental and surgical instruments. The modified version features an enhanced sealing system for the lubricant spray can, incorporating both a screw can seal and an additional O-ring in the connector to ensure a secure fit. The unit is intended for use in a dental clinical setting to maintain instruments before they undergo sterilization. The lubricant spray can is a proprietary component designed exclusively for this unit and cannot be used manually. The device facilitates routine maintenance, ensuring instruments are properly cleaned and lubricated to support clinical instrument longevity and hygiene standards.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical maintenance unit for dental handpieces. Utilizes aerosol-based hydrocarbon propellant lubricant. Features a dual-sealing system for the spray can interface: screw-thread sealing and an integrated O-ring connector. Standalone unit.

Indications for Use

Indicated for internal cleaning and purging of old lubricant from rotating dental and surgical instruments prior to sterilization.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• KaVo QUATTROcare

Submission Summary (Full Text)

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# KD71288

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JUL 1 9 2007

SYBRON DENTAL SPECIALTIES Section 111 - 510(k) Summary of Safety and Effectiveness

# Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: June 2007

### Device Name:

- Trade Name KaVo OUATTROcare Modified t
- � Common Name - Dental Handpiece Lubricant/Cleaner
- Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 �

Devices for Which Substantial Equivalence is Claimed:

Kaltenbach & Voigt GmbH. KaVo QUATTROcare 要

#### Device Description:

The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.

#### Intended Use of the Device:

The intended use of the KaVo QUATTROcare Modified is for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The Kul'o QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually.

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K0712888

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# Substantial Equivalence:

The KaV o QUATTROcare Modified is substantially equivalent to other legally marketed devices in the United States. The KaVo QUATTROcare Modified functions in a manner identical to and is intended for the same use as the original version of the KaVo QUATTROcare manufactured by Kaltenbach & Voigt GmbH.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2007

Kavo America Corporation C/O Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K071288

Trade/Device Name: KaVo QUATTROcare Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: May 7, 2007 Received: May 8, 2007

Dear Ms. Boswell:

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 - Ms. Boswell

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). please contact the Office of Compliance at [phone]. 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 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,

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

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# Indications for Use

510(k) Number (if known): K071288

Device Name: KaVo OUATTROcare

Indications For Use:

KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually.

NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DDS for Dr. Susan Kummer Page 1 of 1

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

2071298 510(k) Number: