(181 days)
Not Found
Not Found
No
The summary describes a mechanical air abrasion system and does not mention any AI or ML components or functionalities.
No
The device is described as performing air abrasion procedures for etching and preparing surfaces for composite restorations, which are considered restorative rather than therapeutic actions.
No
Explanation: The device is described as performing "intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations," which are therapeutic or preparatory procedures, not diagnostic ones.
No
The device description explicitly states it incorporates hardware components like an air abrasion system, unit housing, membrane air dryer, and a handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform intra-oral air abrasion procedures for etching and preparing surfaces for composite restorations. This is a dental procedure performed directly on the patient's body.
- Device Description: The description details a system for air abrasion, including a handpiece and air dryer. This aligns with a device used for physical manipulation within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens in vitro (outside the body) to provide information about a person's health.
Therefore, the Micadent is a dental device used for a therapeutic/preparatory procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.
Product codes
KOJ
Device Description
The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral
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
Not Found
Key Metrics
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1998
Mr. John W. McPeek President ASI Medical, Incorporated 14550 East Easter Avenue, Suite 1000 Englewood, Colorado 80112
K974488 Re : Airprep System - Model 9001 Trade Name: Requlatory Class: III Product Code: KOJ November 25, 1997 Dated: November 26, 1997 Received:
Dear Mr. McPeek:
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. ਰ 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 requlation (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 requlation 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
1
Page 2 - Mr. McPeek
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 (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 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.fdg.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
2
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510(k) Number (if known): Applied 11/25/97
Table-Top Air Abrasion Instrument
Table -Top
Indications For Use:
Device Name:
The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.
A.z Abrasist
The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.
The AirPrep System is substantially similar in design and function as the Micadent manufactured by Hampton Research and marketed by Medidenta International. The Micadent will be supplied to ASI as a completed product. The AirPrep will be only marketed for the same purposes as the Micadent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Conurrence of CDRH, Office of Device Evaluation (ODE) | |||||
|---|---|---|---|---|---|
| Suser Rubines | |||||
| (Division Sign-Off) | |||||
| Division of Dental, Infection Control, and General Hospital Devices | |||||
| 510(k) Number | 1974488 | ||||
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use (Optional Format 1-2-96) |
DEC-02-1997 12:03
301 480 3802
96% P.02
TOTAL P.03