DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125

K041141 · Dentsply Intl. · EFB · Jun 16, 2004 · Dental

Device Facts

• Record ID: K041141
• Device Name: DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
• Applicant: Dentsply Intl.
• Product Code: EFB · Dental
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The AirFlow handy is a dental handpiece intended for use in the cleaning and the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers. The device can also be used to clean the following: implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching; crowns and bridges; fixed bands and brackets prior to placement on orthodontic appliances.

Device Story

AirFlow handy is a hand-held dental handpiece; connects to standard turbine tube for air/water supply. Device utilizes internal powder chamber for bicarbonate powder; generates air/powder stream enveloped by water spray upon activation. Used by dental professionals in clinical settings to clean/polish tooth surfaces; remove soft deposits/discoloration; prepare teeth for restorative/orthodontic procedures. Output is directed spray; enables surface cleaning prior to bonding/treatment. Benefits include efficient surface preparation and stain removal. Device features fixed or rotating nozzles (90°/120°).

Clinical Evidence

Bench testing only. Testing supported a minimal reuse life of 130 treatments (15 hours of use). Connection-integrity testing confirmed the turbine adaptor remained intact at 10 bar air pressure.

Technological Characteristics

Hand-held dental handpiece; air/water/powder delivery system. Features fixed or rotating nozzles (90°/120°). Integrated powder chamber. Mechanical operation via turbine air/water supply. No software or electronic components.

Indications for Use

Indicated for cleaning and polishing tooth surfaces, removing soft deposits and extrinsic stains, and preparing teeth for dental procedures including composite fillings, inlays, laminate veneers, shade matching, fluoridation, bleaching, crowns, bridges, and orthodontic appliance placement.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• AirFlow SII (K900709)
• Prophyflex 2, Model 2012 (K973876)

Submission Summary (Full Text)

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# 510(k) Summary for AirFlow handy

### SPONSOR 1.

Electro Medical Systems SA Ch. Vuarpillière 31 1260 Nyon SWITZERLAND

Daniel Rochat, Operational Director Contact Person: 41-22-994 47 18, 41-22-994 47 00 Telephone:

September 9, 1999 Date Prepared:

### DEVICE NAME 2.

| Proprietary Name: | AirFlow handy |
|----------------------|----------------------------------|
| Common/Usual Name: | Dental handpiece |
| Classification Name: | Dental handpiece and accessories |

### PREDICATE DEVICES 3.

- AirFlow SII (K900709) .
- Prophyflex 2, Model 2012 (K973876) .

### DEVICE DESCRIPTION 4.

The AirFlow handy is a hand-held device containing air and water lines, powder The Alfriow name) is a inflow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the tube willen supplies and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.

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### INTENDED USE ડ.

The AirFlow handy is a dental handpiece intended for use in the cleaning and The Fill 10W halls) the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth our be such as the placement of composite fillings, inlays, and laminate veneers.

The device can also be used to clean the following:

- implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
- crowns and bridges .
- fixed bands and brackets prior to placement on orthodontic appliances. .

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Both the proposed device and the substantially equivalent devices are intended for use in the cleaning and polishing of teeth. Unlike the predicate AirFlow SII, the proposed device does not function as a scaler.

The operational principle of the proposed device is identical to that of the AirFlow SII and the Prophyflex 2. The cleaning and polishing action is produced by the projection of air, water, and bicarbonate powder onto the tooth surface. The proposed device is supplied with a fixed nozzle or a rotating nozzle with a tip angle of 90° or 120°. The fixed AirFlow nozzle is identical to the nozzle used for the predicate AirFlow SII. The rotating AirFlow nozzles are identical to the predicate AirFlow SII except for minor design modifications to permit the tip to rotate. The rotating nozzle is also similar to the Prophyflex II nozzle.

The AirFlow handy differs from the AirFlow SII in size and in the location of the powder chamber. The proposed AirFlow handy is smaller than the AirFlow SII, and, like the Prophyflex 2, the powder chamber has been incorporated into the body of the device.

The differences between the proposed and predicate devices are restricted to minor differences in size, design, and materials and do not impact the safety or effectiveness of the device.

Electro Medical Systems Amendment to K991857 EMS AirFlow handy

9/9/99

Page B-2

24

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### 7. PERFORMANCE TESTING

Testing was performed to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. Connection-integrity testing demonstrated that the connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar.

9/9/99

Electro Medical Systems Amendment to K991857 EMS AirFlow handy

. -

Page B-3

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Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized lines that resemble a person with outstretched arms.

JUN 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dentsply International Mr. Jeffery P. Lehn Mr. Jeffery 1 : Lornorate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K041141

KU41141
Trade/Device Name: Dentsply Cavitron Jet Wave air Polishing Prophylaxis System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 28, 2004 Received: April 30, 2004

Dear Mr. Lehn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales one of the device is substantially equivalent (for the reletenced above and nave decemblics tre to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce proct to that have been reclassified in accordance with the provisions of Amendinens, of to devroes that have of the United onot require approval of a premarket the rederal Pood, Drug, und Commons , therefore, market the device, subject to the general approval application (1 mm ). - The general controls provisions of the Act include controls provisions of the Hea. "The girling 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 If your device is classified (been additional controls. Existing major regulations affecting (FMA), it may of subject to fact and of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in ther announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S issualled of a basedantines with other requirements
mean that FDA has made a determination that your device the Forders and mean that FDA nas made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regirements, including, but not limited to: registration propotion You must comply with an the Act 3 requirements (21 CFR Part 801); good manufacturing practice and listing (21 CFK Fall 607), laoomig (21 CFR Part 820), and if and 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. The PDF Intialing or seessification 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), If you desire specific advice for your de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binastic or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kein Marley

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K041141

JET WAVE™ SYSTEM Device Name:

Indications for Use

The IET WAVE™ SYSTEM is indicated for air polishing procedures including the removal of a
nd the collection and consembly seebularis; and cleaning tooth surfaces prior to bo The JET WAVE™ SYSTEM is indicated for air polishing procedures medialing the really
variety of extrinsic stains; general prophylaxis; and cleaning tooth surfaces prior to bon sealant procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 2) CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Fraser

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Der 510(k) Number: