(686 days)
Not Found
Not Found
No
The summary describes a disposable dental air abrasion handpiece with no mention of AI, ML, image processing, or data-driven performance metrics.
No
This device is for cutting and preparing tooth structure, which is a mechanical action, not a therapeutic treatment of disease or condition.
No
The device is used for cutting and preparation of tooth structure, not for diagnosing medical conditions.
No
The device description explicitly states "Disposable Dental Air Abrasion Handpiece," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical cutting and preparation of tooth structure and dental restorations. This is a mechanical procedure performed directly on the patient's body.
- Device Description: It's described as a "Disposable Dental Air Abrasion Handpiece," which is a tool used for physical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not involve the analysis of specimens.
Therefore, this device falls under the category of a dental instrument used for surgical/mechanical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparation. Abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures. For Use by Dentists Only.
Product codes
KOJ
Device Description
DispDrillTM
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces, enamel, dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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)
PrepStar™ by Danville Engineering Inc.
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 and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH - HUMAN SERVICES - USA" in a circular arrangement.
AUG 6 2001
1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Reuben Hertz, DDS, FAGD Vice President, KIS Products, Inc. 2318 Sea Island Drive Fort Lauderdale, FL 33301
K993124 Re : Disposable Dental Air Abrasion Handpiece Trade Name: Regulatory Class: III Product Code: KOJ Dated: September 16, 1999 September 20, 1999 Received:
Dear Mr. Hertz:
We have reviewed your Section 510(k) notification of intent to we have levice your beloced above and we have determined the market increatially equivalent (for the indications for device Is subscancially equivalore (colors) to devices marketed in interstate use stated in tho May 28, 1976, the enactment date of the Commerce prior co nayents, or to devices that have been Medical Device Amendically, sith the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the ACC. The general onnual registration, listing of Include requirmanufacturing practice, labeling, and devices, good manazacous 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 be Bubjeot of Becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ਼ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices; General (GMP) regulation (21 CFR Part 820) and that, through periodic (Gri ) regulacions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif back abbamay regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Mr. Hertz
this response to your Please note: the Federal Register. the Federal Register. Freadorion does not affect any premarker notification submited at ations 531 through 542 of obligation you might have uner bestronic Product Radiation the Act for devices under the Eccocient was or regulations.
This letter will allow you to begin marketing your device as This letter will allow you co begin attification. The FDA described in your 510\x7 prematic of your device to a legally
finding of substantial equivalence of classification for your finding of substancial equivalies of plassification for your marketed predicate device resures in a claboration of the market.
If you desire specific advice for your device on our labeling If you desire specific acvice rolled roll on the office of regulation (21 CFR Farc 001 and se contact the Office of vitro diagnostic devices), prease otionally, for questions on Compliance at (301) 394-4022. Friday device, please contact the promotion and advertising on your ac3935 Pilso, please note the regulation entitled, "Misbranding by reference to the regulation entification" (21 CFR 807.97) Other general premarket notification - (2) cir car car the Act may be information on your responsible and Manufacturers Assistance obtained from the bivision or 6m8-2041 or (301) 443-6597 or at at its toll-lree number (800) 050 aa. v/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
Page of
| 510(k) Number (if known): | not issued K993124 |
|---|---|
| --------------------------- | -------------------- |
DispoDrill™ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures.
Indications for use are identical to PrepStar™ by Danville Engineering Inc.
For Use by Dentists Only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saisen Runney
(Division Sign-Off) Civision of Dental, Infection Control. and General Hospital Device । यह 5 : O(k) Number J Over-The-Counter Use_ OR
Prescription Use (Per 21 CFR 801.109)