(72 days)
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.
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.
This looks like a 510(k) premarket notification for a dental handpiece lubricant/cleaner device. The provided text does not contain any information regarding acceptance criteria, study design, or performance metrics for the KaVo QUATTROcare Modified device. It primarily focuses on the device's description, intended use, and claim of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.
If you have a different document that details the performance study for K071288, please provide it, and I would be happy to analyze it for the requested information.
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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 (714) 516-7484 - Phone (714) 516-7488 - 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.