(288 days)
Not Found
Not Found
No
The summary describes a mechanical device using air-driven particles for surface roughening, with no mention of AI or ML.
No
The device is used to prepare teeth for restorative procedures by roughening surfaces and removing tooth structure/materials. It is not indicated for treating or preventing disease.
No
Explanation: The device description states its use is for cavity preparation and roughening dental surfaces, which are therapeutic and restorative procedures, not diagnostic ones.
No
The device description explicitly states it is an "AC-powered cavity preparation device" that "uses air-driven particles," indicating it is a hardware device with mechanical components, not software only.
Based on the provided information, the MicroJet System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The MicroJet System is a dental device used for physical preparation of teeth and dental restorations. It operates directly on the patient's teeth and existing dental materials.
The description clearly indicates its function is mechanical preparation of dental surfaces, not the analysis of biological samples.
N/A
Intended Use / Indications for 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.
Product codes
KOJ
Device Description
MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6080 Airbrush.
(a)
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.(b)
Classification. Class II. 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.”
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 1997
Mr. Hector Jimenez-Billini Mr. hector ofmence and Regulatory Affairs Manager Midwest Dental Products Corporation 901 West Oakton Street Des Plaines, Illinois 20018
Re : K964755 Microjet Cavity Preparation System Trade Name: Requlatory Class: III KOJ Product Code: 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 The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Jimenez-Billini
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 described in your six wi puivalence 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fida.gov/cdrh/dsmamain.html".
Sincerely yours,
L. A. Watford.
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
O
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Dentsply Midwest. The word "Dentsply" is in a bold, sans-serif font and is stacked on top of the word "Midwest", which is also in a bold, sans-serif font. The logo is black and white.
Midwest Dental Products Division of DENTSPLY International 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 Fax (847) 640-6165
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
Heekining 11/25/96
Quality Assurance and Regulatory Affairs Manager
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi
510(k) Number K964755
Prescription Use
(Per 21 CFR 801.109)