(683 days)
Intra-orally to surface clean and remove stain from teeth and dental restorations.
For Use by Dentists and Hygienists only.
Disposable Dental Air Polishing Handpiece
This document is an FDA 510(k) clearance letter for a disposable dental air polishing handpiece (Trade Name: Disposable Dental Air Polishing Handpiece, later identified as DispoProphy™). This clearance letter does not contain the detailed study information needed to fully answer your request regarding acceptance criteria and a study proving those criteria are met.
The letter explicitly states: "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... to devices marketed in interstate commerce prior to May 28, 1976, or to devices which have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This means that the device was cleared based on substantial equivalence to a predicate device (MiniPolisher™ by Henry Schein), not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for this particular device. In 510(k) submissions, manufacturers often rely on existing data and performance of the predicate device to argue for substantial equivalence, or conduct bench testing to ensure their device matches the performance of the predicate.
Therefore, most of the information you requested cannot be extracted from this document. It does not describe a new study with acceptance criteria and results for the cleared device.
However, I can provide the limited information that is available from the document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a direct performance table for the DispoProphy™ device itself. The clearance is based on substantial equivalence to the predicate device, the MiniPolisher™ by Henry Schein. Therefore, the "acceptance criteria" implicitly are that the device performs at least as well as and is as safe and effective as the predicate device for its intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. Substantial equivalence typically relies on bench testing, comparison to the predicate, and existing clinical understanding of similar devices, rather than a new clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in this document. Ground truth establishment with experts is usually part of clinical trials, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental air polishing handpiece, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for a new study. For substantial equivalence, the "ground truth" is often the established safety and efficacy profile of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
What the document does tell us:
- Trade Name: Disposable Dental Air Polishing Handpiece (later identified as DispoProphy™)
- Regulatory Class: II (Initially listed as III, then corrected to II, which is typical for 510(k) devices, as Class III devices usually require PMA) - Correction: The document states "Regulatory Class: III" but then immediately indicates it's a 510(k) clearance, which is for Class I or II devices. This is a common typo where the Classification is later clarified as Class II or I upon review or reclassification. The 510(k) number and statement of substantial equivalence confirm it's not a Class III device requiring PMA.
- Product Code: KOJ
- Predicate Device: MiniPolisher™ by Henry Schein
- Indications For Use: "Intra-orally to surface clean and remove stain from teeth and dental restorations." "For Use by Dentists and Hygienists only."
To get the detailed study information you're looking for, you would typically need to review the original 510(k) submission (K993182) publicly available on the FDA website. However, even then, for a substantial equivalence claim, the studies may involve bench testing to confirm material properties and mechanical performance equivalent to the predicate, rather than extensive new clinical trials with a test set of human patients.
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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
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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
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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
§ 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.”