PROULTRA PIEZO ULTRASONIC

K113430 · Satelec - Acteon Group · ELC · Feb 23, 2012 · Dental

Device Facts

• Record ID: K113430
• Device Name: PROULTRA PIEZO ULTRASONIC
• Applicant: Satelec - Acteon Group
• Product Code: ELC · Dental
• Decision Date: Feb 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with dental tips for scaling, periodontics, prosthesis and endodontic Dental Applications.

Device Story

The ProUltra Piezo Ultrasonic is a dental ultrasonic generator used by dental professionals in clinical settings. It functions by driving specialized dental tips via ultrasonic vibration to perform scaling, periodontal procedures, prosthetic preparation, and endodontic treatments. The device transforms electrical energy into mechanical ultrasonic oscillations, which are delivered to the tooth surface or root canal via the attached tip. The clinician operates the device to remove calculus, plaque, or dental tissue, or to assist in endodontic cleaning and shaping. The output is controlled mechanical vibration, which facilitates precise dental interventions, improving efficiency and clinical outcomes for patients undergoing routine or specialized dental care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental ultrasonic generator; piezoelectric transducer technology; electrical energy source; handheld dental handpiece form factor; intended for professional dental use.

Indications for Use

Indicated for dental applications including scaling, periodontics, prosthesis, and endodontics in patients requiring dental ultrasonic treatment.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Satelec-Acteon Group C/O Mr. Rick Rosati Quality Manager Acteon, Incorporated . 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K113430

Trade/Device Name: ProUltra Piezo Ultrasonic Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 9, 2012 Received: February 10, 2012

Dear Mr. Rosati:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act research Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocomonay, therefore, market the device, subject to the general approvincians of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, legallements for unnual regionations and adulteration. Please note: CDRH does not evaluate informations against institution. 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 (1 MIx), It may=00_babyon-o-ade of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements conceming your device in the Federal Register.

FEB 2 3 2012

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## Page 2- Mr. Rosati

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn for

Anthony D. Watson, BS, MS, MBA 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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## Section 04 – Indication for Use

## Indications for Use

KI18430

510(k) Number (if known):

Device Name:

ProUltra Piezo Ultrasonic

Indications for Use:

The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Susan Penroe

(Division Sign-Off) (Division Sign-Off)
Division of Anesthealbagy, General Hospital
Division of Anesthealbagy, Canada Caujane Division Control, Dental Devices

510(k) Number: K113430