(211 days)
Not Found
Not Found
No
The summary describes a dental microetcher, a mechanical device for preparing tooth surfaces. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is described as an "Microetcher AP" used for cutting, preparation, and surface roughening of tooth structures, which are procedures rather than direct therapeutic treatments. While these actions are preparatory to restorative procedures, the device itself is not described as directly treating or curing a disease or condition.
No
The device's intended use is for cutting, preparation, and roughening of tooth and dental structures, which are procedural and preparatory actions, not diagnostic ones.
No
The device description "Microetcher AP" and the intended use involving "cutting and preparation of tooth structure" strongly suggest a physical device, likely a dental microetcher, which is a hardware tool. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the patient's tooth structure (cutting, preparation, removal, roughening). This is a direct clinical intervention, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "Microetcher AP," which is a tool used for physical manipulation of tooth surfaces.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and performed directly on the patient.
N/A
Intended Use / Indications for Use
Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite resin restorations. Surface roughening of enamel,dentin, and metal dental structures prior to adhesive resin bonding.
Product codes
KOJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure, enamel, dentin, dental structures
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPA" is visible below the bird. The text "DEPT. OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 1997
Mr. Craig R. Bruns Danville Engineering, Incoporated 2021 Omega Drive San Ramon, California 94583
K970589 Re : Microetcher Ap Trade Name: Requlatory Class: II Product Code: KOJ February 11, 1997 Dated: Received: February 18, 1997
Dear Mr. Bruns:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Party
1
Page 2 - Mr. Bruns
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 at (301) 443-6597.
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
Page of
510(k) Number: K97-0589
Device Name: Microetcher AP
Indications for Use:
Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite resin restorations. Surface roughening of enamel,dentin, and metal dental structures prior to adhesive resin bonding.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Sheen Run
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K970589
Prescription Use / (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formal 1-2-96)