DISPOPROPHY

K993182 · Kis Products · KOJ · Aug 6, 2001 · Dental

Device Facts

• Record ID: K993182
• Device Name: DISPOPROPHY
• Applicant: Kis Products
• Product Code: KOJ · Dental
• Decision Date: Aug 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2

Intended Use

Intra-orally to surface clean and remove stain from teeth and dental restorations. For Use by Dentists and Hygienists only.

Device Story

The DispoProphy is a disposable dental air polishing handpiece used by dentists and hygienists. It functions intra-orally to clean surfaces and remove stains from natural teeth and dental restorations. The device operates via air polishing technology, delivering a stream of air and abrasive powder to the tooth surface. It is intended for professional clinical use to improve dental hygiene and aesthetic appearance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable air polishing handpiece; air-driven abrasive delivery system; manual operation; intended for intra-oral use.

Indications for Use

Indicated for intra-oral surface cleaning and stain removal from teeth and dental restorations. For use by dentists and dental hygienists only.

Regulatory Classification

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.

Special Controls

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.”

Predicate Devices

• MiniPolisher by Henry Schein (K993124)

Submission Summary (Full Text)

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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 [phone]. Huarver device, please contact Also, please note the promotion and advere at [phone].
the Office of Compliance at [phone]. 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 [phone] or at
at its toll-free number [phone] consideramain html", at its toll-tree number [phone] 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) | <div> <span></span> </div> |

OR
Over-The-Counter Use