MICROJET CAVITY PREPARATION SYSTEM

K964755 · Midwest Dental Products Corp. · KOJ · Sep 11, 1997 · Dental

Device Facts

• Record ID: K964755
• Device Name: MICROJET CAVITY PREPARATION SYSTEM
• Applicant: Midwest Dental Products Corp.
• Product Code: KOJ · Dental
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations. MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.

Device Story

MicroJet System is an AC-powered dental device; utilizes air-driven abrasive particles to abrade/roughen tooth surfaces and restorative materials; used by dental professionals in clinical settings for cavity preparation and surface treatment; facilitates removal of tooth structure and restorative materials; aids in preparation for dental restoration; output is mechanical abrasion of target dental surfaces; benefits include efficient material removal and surface preparation for restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered air-abrasion system; utilizes air-driven particles for mechanical surface roughening and material removal; standalone dental unit.

Indications for Use

Indicated for use by dental professionals for the removal of tooth structure and restorative dental materials, and for the preparation of teeth for dental restoration.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 11 1997

Mr. Hector Jimenez-Billini
Quality Assurance and Regulatory Affairs Manager
Midwest Dental Products Corporation
901 West Oakton Street
Des Plaines, Illinois 60018

Re: K964755
Trade Name: Microjet Cavity Preparation System
Regulatory Class: III
Product Code: KOJ
Dated: June 27, 1997
Received: June 27, 1997

Dear Mr. Jimenez-Billini:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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DENTSPLY MIDWEST

Midwest Dental Products
Division of DENTSPLY International
901 West Oakton Street
Des Plaines, IL 60018-1884
Phone [phone]
Fax [phone]

# INTENDED USE STATEMENT

MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.

MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.

Hector Jimenez-Billini
11/15/96
Quality Assurance and Regulatory Affairs Manager

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 159601755

Prescription Use ☑
(Per 21 CFR 801.109)

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