CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM

K130862 · Dentsply Intl., Inc. · ELC · Jul 23, 2013 · Dental

Device Facts

• Record ID: K130862
• Device Name: CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
• Applicant: Dentsply Intl., Inc.
• Product Code: ELC · Dental
• Decision Date: Jul 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for: - Stain removal, - Prophylaxis of orthodontic patients, - Preparing tooth surfaces prior to bonding and sealant procedures, and - Implant debridement

Device Story

Air polishing unit delivering air/water/powder mixture to tooth enamel via insert tip; polishes without direct contact. Uses water-soluble prophy powders (sodium bicarbonate or aluminum trihydroxide). Features: Tap-On™ wireless foot pedal, prophy mode auto cycles, illuminated diagnostic display, automated purge function, detachable sterilizable handpiece, swivel cable with lavage control. Used in dental clinics by professionals. Connects to external air/water lines and AC power. Output: controlled spray for cleaning/polishing. Benefits: efficient removal of stains/deposits, preparation for dental procedures, and safe implant maintenance.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including stain removal, enamel abrasion, functional verification, and electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Air polishing system; utilizes water-soluble powders. Features wireless/wired foot pedal (two-position: rinse/polish), detachable autoclavable handpiece, and lavage control. Connectivity: external air/water lines, AC power. Software: embedded firmware for auto-cycles, purge function, and diagnostic display. Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971 (risk management).

Indications for Use

Indicated for general prophylaxis, periodontal treatments, and operative dentistry, including stain removal, orthodontic patient prophylaxis, tooth surface preparation for bonding/sealants, and implant debridement.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• Dentsply International Cavitron® SPS Ultrasonic Scaler and Prophy-Jet® (K970342)
• Dentsply International Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece (K052334)
• EMS Electro Medical Systems, S.A. EMS Air-Flow Master Piezon (K110173)
• Satelec Air-N-Go (K110379)

Reference Devices

• Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342)
• Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188)
• Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697)
• Cavitron® Jet Air Polishing Insert (K041141)

Submission Summary (Full Text)

{0}------------------------------------------------

K) 30862

## SECTION 5- 510(k) SUMMARY

Cavitron® Prophy-Jet® Air Polishing Prophylaxis System

Image /page/0/Picture/4 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word appears to be a logo or brand name. The font is slightly distressed, giving it a textured appearance.

### DENTSPLY Internationa

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 1800) 877-0020 Fax [phone] ww.dentsply.com

- Submitter Information: 1.
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

JUL 2 3 2013

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

March 19, 2013 Date Prepared:

#### 2. Device Name:

- Proprietary Name: Cavitron® Prophy-Jet® Air Polishing Prophylaxis System .
- Classification Name: Ultrasonic scaler .
- CFR Number: 872.4850 o
- Device Class: II o
- Product Code: ELC o

#### 3. Predicate Device:

The proposed Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is substantially equivalent to the following legally marketed devices:

- Dentsply International Cavitron® SPS Ultrasonic Scaler and Prophy-Jet®, . K970342, product code ELC.
- Ultrasonic Scaler with Sterimate International Cavitron® RF Dentsply . Handpiece, K052334, product code ELC.
- EMS Electro Medical Systems, S.A. EMS Air-Flow Master Piezon, K110173, . Product Codes ELC, EFB, EJR
- Satelec Air-N-Go, K110379, Product Code EFB .

The following accessories used with the proposed Cavitron® Prophy-Jet® Air Polishing Prophylaxis System were previously cleared by FDA:

- Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) .
- Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) .
- Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697) .
- Cavitron® Jet Air Polishing Insert (K041141) .

{1}------------------------------------------------

#### 4. Description of Device:

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.

#### Intended Use: 5.

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:

- Stain removal, .
- Prophylaxis of orthodontic patients, .
- Preparing tooth surfaces prior to bonding and sealant procedures, and .
- . Implant debridement

#### Identification of Risk Analysis Method: 6.

Risk analysis was performed on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System utilizing an FMEA process based on ISO 14971. The results of the risk analysis performed on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System concluded that all device design controls and process controls will be able to mitigate known potential failures and effects. In addition, performance testing and electrical safety testing were performed to mitigate other potential risks.

#### Description of Safety and Substantial Equivalence: 7.

#### Technological Characteristics: 7.1

The technological characteristics of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System are very similar to the predicate devices; Cavitron® SPS Ultrasonic Scaler and Prophy Jet (K970342) and Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece (K052334). All devices operate by the use of a foot pedal. The foot pedal in the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece (K052334) can be connected to the system with a wire or by wireless means. The foot pedals of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® SPS Ultrasonic Scaler and Prophy Jet (K970342) have a two position operation. The first position is for rinsing, and second position is for air polishing. The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® SPS Ultrasonic Scaler and

{2}------------------------------------------------

Prophy Jet (K970342) both utilize the same water-soluble air polishing prophy powders and air polishing insert. The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece (K052334) both have a handpiece which can be removed to autoclave. Both the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® SPS Ultrasonic Scaler and Prophy Jet (K970342) have a selector pointer on the top of the powder bowl which determines the amount of prophy powder which can be delivered to the patient. Both systems require the same input air and water pressure to function correctly. The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System and the predicate Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece (K052334) have lavage control on the handpiece to select a water flow rate for system operation,. All lavage controls deliver the same range of water flow to the patient.

The proposed Cavitron® Prophy-Jet® Air Polishing Prophylaxis system has added indications for stain removal, prophylaxis of orthodontic patients, preparing tooth surfaces prior to bonding and sealant procedures, and implant debridement. Although these indications are not included in the cleared indications of the air polishing predicate Cavitron® SPS Ultrasonic Scaler and Prophy Jet (K970342), they are cleared indications for newer air polishing devices. Specifically, the Satelec Air-N-Go dental prophylaxis handpiece (cleared under premarket notification K110379) and the EMS Medical Systems Air-Flow Master Piezon (cleared under premarket notification K110173) include indications for the removal of, "soft deposits and areas of discoloration", the preparation of teeth for, "conventional dental procedures such as the placement of composite fillings", "plaque and stain removal for orthodontic patients", and "cleaning of implant fixtures" and abutments. There are also multiple literature references that make a case for the safety of cleaning implants using an air polishing device.

#### Non-Clinical Performance Data: 7.2

Performance testing focused on verification of design, stain removal, enamel abrasion, function and safety of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System. Below is a summary of the testing performed:

- IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General . Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility (2007)
- IEC 60601-1 Medical Electrical Equipment Part 1:General requirements . for basic safety and essential performance (2005)
- FDA -- Guidelines for the Content of Premarket Submissions for Software . Contained in Medical Devices - Software Validation
- Internal specification and testing for handpiece operation, including lavage . control
- Internal specification and testing for autocycle operation .
- Internal specification and testing for indicator lights and user interface . functionality
- Internal specification and testing for radio frequency distance for foot . pedal
- Internal specification and third party testing for stain removal and abrasion �

{3}------------------------------------------------

The results of these performance tests support the substantial equivalence of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System ..

#### 7.3 Clinical Performance Data:

No human clinical data has been provided to support substantial equivalence.

#### Conclusion as to Substantial Equivalence: 7.4

The similarities in design, function, safety and intended use of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System with the legally marketed predicate devices support substantial equivalence. The performance and safety data support the substantial equivalence of the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## July 23, 2013

DENTSPLY International, Incorporated C/O Ms. Helen Lewis Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872

Re: K130862

Trade/Device Name: Cavitron® Prophy-Jet® Air Polishing Prophylaxis System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 19, 2013 Received: June 20, 2013

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# SECTION 4. INDICATIONS FOR USE STATEMENT

KI 30862 510(k) Number (if known):

Device Name: Cavitron® Prophy-Jet® Air Polishing Prophylaxis System

## Indications for Use:

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:

- . Stain removal,
- Prophylaxis of orthodontic patients, .
- Preparing tooth surfaces prior to bonding and sealant procedures, and ●
- Implant debridement .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-off)
Division of Anesthestology, General Hospital Division of Antonious of the Devices

510(k) Number: K130862

Premarket Notification

Cavitron® Prophy-Ject® Air Polishing Prophylaxis System

DENTSPLY International

000010