(683 days)
Not Found
No
The summary describes a mechanical device for cleaning teeth and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any information about data sets or performance metrics typically associated with AI/ML devices.
No.
The device's intended use is to "surface clean and remove stain from teeth and dental restorations," which is a cosmetic or maintenance function, not a therapeutic one aimed at treating or preventing a disease or condition. Its predicate device also suggests a similar non-therapeutic application.
No
The device is used for cleaning and removing stain from teeth, which are therapeutic and maintenance functions, not diagnostic.
No
The device description explicitly states "Disposable Dental Air Polishing Handpiece," which is a physical 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 "Intra-orally to surface clean and remove stain from teeth and dental restorations." This describes a physical action performed directly on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Disposable Dental Air Polishing Handpiece." This is a tool used for a dental procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for a dental cleaning procedure performed directly on the patient, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intra-orally to surface clean and remove stain from teeth and dental restorations.
Indications for use are identical to MiniPolisher™ by Henry Schein.
Product codes
KOJ
Device Description
Disposable Dental Air Polishing Handpiece
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and dental restorations (intra-orally)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists and Hygienists only.
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)
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 shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 2001
Reuben Hertz, DDS, FAGD Vice President KIS Products, Inc. 2318 Sea Island Drive 2316 Sea Ibiaale, Florida 33301
K993182 Re:
Disposable Dental Air Polishing Handpiece Trade Name: Regulatory Class: III Product Code: KOJ September 17, 1999 Dated: September 23, 1999 Received:
Dear Dr. Hertz:
We have reviewed your Section 510 (k) notification of intent to We have reviewed your Section 310 (x) hours have determined the market the device referenced above and we indications for device is substantially equivalence (ror marketed in interstate
use stated in the enclosure) to devices marketed in interse use stated in the enclosure, the encar ment date of the Medical Device Amendments, of to develop sions of the Federal reclassified in accordance with act (Act). You may, therefore, Food, Drug, and Cosmetic Acc (acc), read controls provisions
market the device, subject to the general controls provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general concrear pistration, listing of include requirements for amaxa tice, labeling, and devices, good manufacturing places. The prohibitions a
If your device is classified (see above) into either class II
n it may If your device is classified (see above) two roval), it may i (Special Controls) of Crabbitional controls. Existing major be subject to such addicionar control be found in the Code of regulations arrecting fitle 21, Parts 800 to 895.
Federal Regulations, Title 21, Parts 800 most ca ದ Eederal Regulations, Title Zi, Facto oversumes compliance with
substantially equivalent determination Modial Dovices: General substantially equivalenc actice for Medical Devices:
the Good Manufacturing Practice of and that - through r General the Good Manufacturing Fraccicc 200 and that, through periodic (GMP) regulation (2) Crk Fart our Administration (FDA) will Failure to comply with the GMP verify such assumptions. verify such assumptions. Farlors consembly in addition, FDA
regulation may result in regulatory action. In adevice in regulation may result in regulated, oncerning your device in
may publish further announcements concerners to your may publish further announcements on obles response to your .
the Federal Register. Please note: this response any the rederal hegineer. Submission does not affect any
1
Page 2 - Mr. Hertz
the Federal Register. Please note: this response to your the Federal Register. Frease notes not affect any premarket notification stomesoron accoms 531 through 542 of
obligation you might have the Rootropic Radiation obligation you might have under the Electronic Product Radiations, the Act for devices under the ficcerchis of the many
This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin maification. The FDA
described in your 510(k) premarket notification a lea described in your 5101X premance of your device to a legally
finding of substantial equivaler in a alessification for vour finding of substantial equivalence of your sification for your marketed predicate device results in a crabbidential warket.
If you desire specific advice for your device on our labeling in If you desire specific advice to your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 Crk Farc bor anale contact the Office of vitro diagnostic devices), piease coincass you or questions on Compliance at (301) 394-4022. Huarver device, please contact Also, please note the promotion and advere at (301) 594-4639.
the Office of Compliance at (301) 594-4639. the Othice of Complance at (301) 330 by reference to Other general the regulation chercisa) (21 CFR 807.97). premarket notification" (21 CM 807.97). Sthe Act may be information on your responsibilities ander eno real mail on obtained from the Division of Smart Manar (301) 443-6597 or at
at its toll-free number (800) 638-2041 consideramain html", at its toll-tree number (800) 650 2011 02 (600) 11.
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of
×993182 510(k) Number (if known):
DispoProphy™ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Intra-orally to surface clean and remove stain from teeth and dental restorations.
Indications for use are identical to MiniPolisher™ by Henry Schein.
For Use by Dentists and Hygienists only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Puner
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993124 |
| Prescription Use (Per 21 CFR 801.109) |
OR
Over-The-Counter Use