(165 days)
Not Found
Not Found
No
The description focuses on a mechanical air-driven device for surface abrasion and does not mention any AI/ML components or functionalities.
No
The device is described as an abrasive tool used to enhance bond strength for dental materials, not to treat a disease or condition.
No
Explanation: The device is described as an air-driven device that abrades surfaces to enhance bond strength of resinous materials, which is a therapeutic or preparatory function, not a diagnostic one.
No
The device description explicitly states it is an "air-driven device" that delivers an "abrasive material," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to abrade dental surfaces to enhance the bond strength of resinous materials. This is a mechanical action performed directly on a patient's teeth or dental materials, not a test performed on a sample taken from the body.
- Device Description: The description confirms it's an air-driven device delivering abrasive material. This aligns with a physical treatment or preparation device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
An air-driven device that permits the user to abrade surfaces of dental materials, either intra- or extra-orally, in order to enhance the bond strength of resinous materials applied to the air-abraded surfaces and polymerized thereon.
Product codes
KOJ
Device Description
AEROETCHER may be described as an air-driven device that delivers an abrasive material (50um-grit aluminum oxide) to a substrate in order to enhance the bond strength of polymerizable resinous material to that substrate. It is substantially equivalent to the cited predicate devices in its mode of operation, but differs from them in cosmetic design and triggering mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
MAR 10 1998
:: イ
Submitter:
Contact:
Submission Date:
Trade Name:
Common Name:
Classification Name:
Equivalence:
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
Description/Intended Use:
K973679
510(k) SUMMARY
Parkell Products Inc. 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: 516-249-1134 FAX: 516-249-1242
Nelson J. Gendusa, DDS Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735
22 September, 1997
AEROETCHER
Sandblaster
Airbrush
MICROETCHER; ACCU-PREP
AEROETCHER may be described as an air-driven device that delivers an abrasive material (50um-grit aluminum oxide) to a substrate in order to enhance the bond strength of polymerizable resinous material to that substrate. It is substantially equivalent to the cited predicate devices in its mode of operation, but differs from them in cosmetic design and triggering mechanism.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the staff and a snake winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Nelson J. Gendusa, DDS ·Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735
Re : K973679 Trade Name: AEROETCHER Requlatory Class: III Product Code: KOJ Dated: September 23, 1997 September 26, 1997 Received:
Dear Dr. Gendusa:
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 requlations 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Dr. Gendusa
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.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
3
510(k) Number (if known):
Device Name:
AEROETCHER
Indications For Use:
An air-driven device that permits the user to abrade surfaces of dental materials, either intra- or extra-orally, in order to enhance the bond strength of resinous materials applied to the air-abraded surfaces and polymerized thereon.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. R973679
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)