PIEZOSURGERY WHITE

K151248 · Mectron S.P.A. · DZI · Sep 4, 2015 · Dental

Device Facts

• Record ID: K151248
• Device Name: PIEZOSURGERY WHITE
• Applicant: Mectron S.P.A.
• Product Code: DZI · Dental
• Decision Date: Sep 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piezosurgery White 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 White is a table-top piezoelectric ultrasonic device for oral surgery and dental procedures. System includes console, handpiece, footswitch, and various stainless steel tip inserts. Console contains ultrasonic generator, irrigation peristaltic pump, and microprocessor control board. Operator uses touch panel to select treatment mode (Implant, Cortical, Cancellous, Special, Perio, Endo) and irrigation flow rate. Footswitch activates ultrasonic vibration and irrigation simultaneously. Piezoelectric transducer in handpiece converts electrical signals into mechanical micro-vibrations (24-36 kHz) at the tip. Device used by dental professionals in clinical settings. Output provides precise bone cutting and dental cleaning; irrigation prevents overheating. Benefits include minimally invasive bone surgery and efficient dental maintenance. New inserts (PR1, PR2) mimic manual periosteal elevators for membrane detachment.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (working frequency, leakage current, ultrasonic power). Sterilization validated per ISO 17665-1 and ISO 14937. FEA and bench testing verified new inserts (PR1, PR2) resonate within the device's functional frequency range.

Technological Characteristics

Piezoelectric ultrasonic generator; 24-36 kHz frequency range; 25W max output. Stainless steel inserts. Table-top console with peristaltic pump, touch interface, and footswitch. Microprocessor-based control with automatic resonance frequency tuning. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-60. Sterilization via autoclaving.

Indications for Use

Indicated for oral surgical procedures (bone cutting, osteotomy, osteoplasty, drilling), scaling (calculus/plaque removal), periodontology (debridement, irrigation), endodontics (root canal procedures), and restorative/prosthetic dentistry (cavity prep, prosthesis removal, condensation).

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.

Predicate Devices

• Piezosurgery Touch (K122322)

Submission Summary (Full Text)

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

September 4, 2015

MECTRON S.p.A. c/o Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome ITALY

Re: K151248

Trade/Device Name: Piezosurgery White Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: II Product Code: DZI, ELC Dated: June 4, 2015 Received: June 8, 2015

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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Page 2 - Mr. Roger Gray

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 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/Resourcesfor You/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,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151248

Device Name PIEZOSURGERY WHITE

### Indications for Use (Describe)

The Piezosurgery White 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Image /page/3/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with a series of gray circles of increasing size along the line. The circles are evenly spaced and appear to be part of a logo or branding element.

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

## medical technology

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. [e-mail]

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

### ADMINISTRATIVE INFORMATION 1.

| Type of 510(k) submission: | Traditional |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Submission date: | 27 August 2015 |
| 510(k) Submitter: | MECTRON S.p.a<br>Via Loreto 15<br>16042 Carasco - (GE) - ITALY |
| | Phone: [phone]<br>Fax: [phone] |
| 510(k) Contact Person: | Roger Gray<br>VP, Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania, 10<br>00153 Rome, Italy |
| | Phone: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Manufacturer: | MECTRON S.p.a<br>Via Loreto 15<br>16042 Carasco - (GE) - ITALY |
| | Establishment Registration Number: 3003933619 |
| 2. | DEVICE |
| Trade name of the device: | Piezosurgery White |
| Common Name/Regulation Description: | Bone cutting instrument and accessories |
| Classification Regulation: | 21 CFR 872.4120 |
| FDA Panel: | Dental |
| Product Code: | DZI ELC |
| Classification: | Class II |

#### 3. IDENTIFICATION OF THE PREDICATE DEVICE

The substantial equivalence of the subject device is based on the following legally marketed predicate device

| Trade name | Manufacturer | Product Codes | 510(k) Number | Decision Date |
|--------------------|---------------|---------------|---------------|---------------|
| Piezosurgery Touch | Mectron S.p.a | DZI, ELC | K122322 | 12/06/2012 |

#### DEVICE DESCRIPTION 4.

The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.

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Image /page/4/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with several gray circles on it. The circles are evenly spaced along the line.

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

## medical technology

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. [e-mail]

The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. The device also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.

Inside the console are located the ultrasonic generator, the electrical power supply module and the microprocessor electronic board that controls and supervises the functional parameters of the device.

The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the footswitch. One external peristaltic pump, intended for delivery of saline solution to the point of use, is attached to the console.

The console is equipped with a keyboard that allows the surgeon to set/control the functions of the device. The keyboard also provides monitoring information, by means icons, in case of malfunction of the device. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch.

The ultrasonic generator of the Piezosurgery White is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.

The touch panel of the console allows setting of the following treatment/operative parameters:

- Six different types of treatment (IMPLANT, CORTICAL, CANCELLOUS, SPECIAL, PERIO, . ENDO):
- Seven different levels of irrigation (from 0 to 6); .
- . The "pump/flush" function.

The Piezosurgery White uses piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the tip insert attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.

The ultrasonic generator electronics and locates the resonant frequency of the transducer/insert combination, which varies according to the geometry/morphology of the tip insert in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery White handpiece transducer and family of inserts are designed to resonate in this range of frequencies.

The Piezosurgery White complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

#### INTENDED USE/INDICATIONS FOR USE 5.

Piezosurgery White 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.

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Image /page/5/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with five gray circles of varying sizes along the line. The circles are evenly spaced, with the smallest circle on the left and the largest circle on the right.

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

## medical technology

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. [e-mail]

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

Piezoelectric ultrasonic technology is used both by the subject and the predicate device to generate mechanical micro-vibrations of the insert connected to the handpiece. The subject device and predicate device share many characteristics, including identical piezoelectric transducers and ultrasonic generators, as shown in the following comparison table.

| Item | Subject Device<br>Piezosurgery White | Predicate Device<br>Piezosurgery Touch | Equivalence |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | MECTRON SPA<br>Via Loreto 15<br>16042 Carasco - Italy | MECTRON SPA<br>Via Loreto 15<br>16042 Carasco - Italy | N/A |
| 510(k) Number | Subject of this submission | K122322 | N/A |
| FDA Panel | Dental | Dental | Same |
| Regulation Number<br>and name | 872.4120 - Bone cutting instrument and<br>accessories | 872.4120 - Bone cutting instrument and<br>accessories<br>872.4850 - Ultrasonic Scaler | Same |
| Product Code | DZI, ELC | DZI, ELC | Same |
| Regulatory Class | Class II | Class II | Same |
| Technological<br>Characteristics<br>(mechanism of<br>action ) | Piezoelectric ultrasonic technology which<br>generates mechanical micro-vibrations of<br>the insert tips. The piezoelectric<br>transducer uses piezoceramic disks to<br>convert the generator's electrical signal to<br>ultrasonic vibration of the insert tip. | Piezoelectric ultrasonic technology which<br>generates mechanical micro-vibrations of<br>the insert tips. The piezoelectric<br>transducer uses piezoceramic disks to<br>convert the generator's electrical signal to<br>ultrasonic vibration of the insert tip. | Same |
| Device type | Table top device | Table top device | Same |
| Indications for Use /<br>Intended Use | Piezosurgery White is a piezoelectric<br>ultrasonic device, consisting of<br>handpieces and associated tip inserts,<br>intended for:<br>● Bone cutting, osteotomy,<br>osteoplasty and drilling in a variety<br>of oral surgical procedures, including<br>implantology, periodontal surgery,<br>surgical orthodontic, and surgical<br>endodontic procedures;<br>● Scaling applications, including:<br>- Scaling: All general procedures for<br>removal of supragingival and<br>interdental calculus & plaque<br>deposits;<br>- Periodontology: Periodontal<br>therapy and debridement for all<br>types of periodontal diseases,<br>including periodontal pocket<br>irrigation and cleaning;<br>- Endodontics: All treatments for<br>root canal reaming, irrigation,<br>revision, filling, gutta-percha<br>condensation and retrograde<br>preparation;<br>- Restorative and Prosthetics:<br>Cavity preparation, removal of<br>prostheses, amalgam condensation,<br>finishing of crown preparations and<br>inlay/onlay condensation. | Piezosurgery Touch is a piezoelectric<br>ultrasonic device, consisting of<br>handpieces and associated tip inserts,<br>intended for:<br>● Bone cutting, osteotomy,<br>osteoplasty and drilling in a variety<br>of oral surgical procedures, including<br>implantology, periodontal surgery,<br>surgical orthodontic, and surgical<br>endodontic procedures;<br>● Scaling applications, including:<br>- Scaling: All general procedures for<br>removal of supragingival and<br>interdental calculus & plaque<br>deposits;<br>- Periodontology: Periodontal<br>therapy and debridement for all<br>types of periodontal diseases,<br>including periodontal pocket<br>irrigation and cleaning;<br>- Endodontics: All treatments for<br>root canal reaming, irrigation,<br>revision, filling, gutta-percha<br>condensation and retrograde<br>preparation;<br>- Restorative and Prosthetics:<br>Cavity preparation, removal of<br>prostheses, amalgam condensation,<br>finishing of crown preparations and<br>inlay/onlay condensation. | Same |
| Item | Subject Device<br>Piezosurgery White | Predicate Device<br>Piezosurgery Touch | Equivalence |
| Main device<br>components | Control unit with integrated irrigation peristaltic pump, electric power supply and ultrasonic generator. Piezoelectric ultrasonic handpiece and cord. Torque wrench to tighten the inserts on the hand piece. Footswitch with cord. Bracket/s for irrigation solution bag. Power supply cord. Range of insert tips to be used according to the dental applications defined by the intended use. Other accessories/attachments. | Control unit with integrated irrigation peristaltic pump, electric power supply and ultrasonic generator. Piezoelectric ultrasonic handpiece and cord. Torque wrench to tighten the inserts on the hand piece. Footswitch with cord. Bracket/s for irrigation solution bag. Power supply cord. Range of insert tips to be used according to the dental applications defined by the intended use. Other accessories and attachments. | Same |
| Transducer<br>technological<br>characteristics | Piezoelectric:<br>The transducer uses four hard<br>piezoceramic disks to convert the<br>generator's electrical signal to ultrasonic<br>vibration of the insert tip. | Piezoelectric:<br>The transducer uses four hard<br>piezoceramic disks to convert the<br>generator's electrical signal to ultrasonic<br>vibration of the insert tip. | Same |
| Automatic<br>resonance frequency<br>tuning | Electronics with automatic frequency<br>tuning. | Electronics with automatic frequency<br>tuning. | Same |
| Modulated amplitude<br>of the ultrasonic<br>signal mode | Yes | Yes | Same |
| Output performance<br>specification | Operational Vibration frequency:<br>24 kHz to ~ 36 kHz.<br>Max. Output: 25 Watt | Operational Vibration frequency:<br>24 kHz to ~ 36 kHz.<br>Max. Output: 25 Watt | Same |
| Supply Voltage | 100 - 240 VAC | 100 - 240 VAC | Same |
| Output Modes | Six output modes identified as Endo,<br>Perio, Special, Cancellous, Cortical and<br>Implant on the touch panel. | Six output modes identified as Endo,<br>Perio, Special, Cancellous, Cortical and<br>Implant on the touch panel. | Same |
| Activation | Footswitch connected to the control<br>console by means of a cord. | Footswitch connected to the control<br>console by means of a cord. | Same |
| Irrigation system | Irrigation bag connected to a peristaltic<br>pump. Adjustable irrigation flow rate. | Irrigation bag connected to a peristaltic<br>pump. Adjustable irrigation flow rate. | Same |
| Adjustable irrigation<br>flow rate. | Seven irrigation flow rates, from<br>0 to 75 ml/min | Seven irrigation flow rates, from<br>0 to 75 ml/min | Same |
| Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Same |
| Electromagnetic<br>Compatibility | Complies with IEC 60601-1-2 | Complies with EN 60601-1-2 which is<br>equivalent to IEC 60601-1-2 | Same |
| Does the device<br>contain software? | Yes | Yes | Same |
| Software Validation | In accordance with FDA Guidance:<br>"Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices" | In accordance with FDA Guidance:<br>"Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices" | Same |
| Parts need to be<br>sterilized | Yes | Yes | Same |
| Recommended<br>sterilization method | Autoclaving (Steam Sterilization) | Autoclaving (Steam Sterilization) | Same |
| Single use parts | Diamond coated inserts | Diamond coated inserts | Same |
| Item | Subject Device<br>Piezosurgery White | Predicate Device<br>Piezosurgery Touch | Equivalence |
| Tip Inserts | Material: Stainless steel<br>The insert tips are secured to the<br>handpiece by a thread, using a torque<br>wrench. | Material: Stainless steel<br>The insert tips are secured to the<br>handpiece by a thread, using a torque<br>wrench.…