PIEZOSURGERY TOUCH

K122322 · Mectron S.P.A. · DZI · Dec 6, 2012 · Dental

Device Facts

• Record ID: K122322
• Device Name: PIEZOSURGERY TOUCH
• Applicant: Mectron S.P.A.
• Product Code: DZI · Dental
• Decision Date: Dec 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; - Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; - Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; - Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Device Story

Piezosurgery Touch is a piezoelectric ultrasonic device for oral surgery and dental procedures. System comprises a control unit, handpieces, and various tip inserts. Operates via ultrasonic vibrations to perform bone cutting, osteotomy, osteoplasty, drilling, scaling, and endodontic/restorative tasks. Used in clinical dental settings by licensed professionals. Device provides precise bone cutting while sparing soft tissue due to ultrasonic frequency modulation. Output is controlled by the clinician via the device interface to adjust power and irrigation settings. Benefits include reduced trauma to surrounding soft tissues during bone surgery and versatile application across multiple dental specialties.

Clinical Evidence

Bench testing only.

Technological Characteristics

Piezoelectric ultrasonic generator; handpiece with interchangeable metal tip inserts; irrigation system; touchscreen interface; class II medical device; dental bone cutting and scaling instrumentation.

Indications for Use

Indicated for patients requiring oral surgical procedures (bone cutting, osteotomy, osteoplasty, drilling), periodontal therapy, endodontic treatments, and restorative/prosthetic dental procedures.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Submission Summary (Full Text)

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K122322

### medical technology

DEC 0 6 2012

Mectron S. p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. [phone] Fax [phone] www.mectron.com

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc .: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 i.v. [e-mail]

# 510(k) Summary in accordance with 21 CFR 807.92

Device Name:

Piezosurgery Touch

Traditional

July 30, 2012

Mectron Spa

3003933619

Mectron Spa

Roger Gray

Italy

Italy

Via Loreto, 15, 16042 Carasco - (GE)

Via Loreto, 15, 16042 Carasco - (GE)

VP, Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10, 00153 Rome, Italy

Manufacturer:

Date of Submission:

FDA Registration Number:

Type of 510(k) submission:

510(k) Owner:

510(k) Contact:

Trade name:

Piezosurgery Touch

Drill, Bone, Powered Ultrasonic scaler

21 CFR 872.4120

Dental

Class II

DZI ELC

Tel: [phone] Fax: [phone]

Common Name/Regulation Description: Bone cutting instrument and accessories Ultrasonic scaler

Device Classification Name

Classification Regulation:

FDA Panel:

Product Codes:

Class:

510(k) for Piezosurgery Touch - K122322

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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and takes up most of the image. The font is a serif typeface.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### December 6, 2012

Mectron S.PA. C/O Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, Italy 00153

Re: K122322

Trade/Device Name: Piezosurgery Touch Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: November 30, 2012 Received: December 3, 2012

#### Dear Mr. Gray:

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.

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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,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

#### Indications for Use

510(k) Number (if known): K122322

Device Name: Piezosurgery Touch

Indications for Use: Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

- · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- · Scaling applications, including:
- · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

| Prescription Use | AND/OR | Over-The-Counter Use | |
|-----------------------------|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | (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)

2012.12.06
Susan Runner DDS, MA
12:17:02 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Davices

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