COMPACT PIEZO LED

K151023 · Mectron S.P.A. · ELC · Aug 5, 2015 · Dental

Device Facts

• Record ID: K151023
• Device Name: COMPACT PIEZO LED
• Applicant: Mectron S.P.A.
• Product Code: ELC · Dental
• Decision Date: Aug 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits; Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation; Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

Device Story

Compact Piezo Led is a microprocessor-based ultrasonic scaler sub-assembly for integration into dental units. It converts electrical signals into mechanical micro-vibrations via a piezoelectric handpiece transducer (four piezoceramic disks). Input signals (power, water flow) are received from the host dental unit; activation occurs via the dental unit's footswitch. The device automatically tunes to the resonant frequency (24–36 kHz) of the attached tip insert. It includes LED illumination for the operative site. Used by dentists/dental professionals in clinical settings for scaling, periodontics, endodontics, and restorative procedures. Benefits include precise calculus removal, irrigation, and improved visibility. Output is mechanical vibration of the tip; clinical decision-making relies on the practitioner's manual control of the handpiece and the dental unit's power/flow settings.

Clinical Evidence

Bench testing only. Evidence includes electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (IEC 80601-2-60). Functional testing confirmed power output, frequency range, and leakage currents. Software verification and validation performed. Direct comparison of functional results with predicate devices confirmed equivalence.

Technological Characteristics

Piezoelectric ultrasonic scaler; 24-36 kHz frequency range; 15W output. Uses four piezoceramic disks for transduction. Integrated into dental units (24 VAC or 32 VDC). Autoclavable handpiece and tips. Stainless steel tips. Software-controlled automatic resonant frequency tuning. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-60.

Indications for Use

Indicated for dental patients requiring scaling, periodontal therapy/debridement, endodontic root canal treatments, or restorative/prosthetic procedures including cavity preparation and implant cleaning.

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

• Compact Piezo P2k (K102218)
• Multipiezo (K140965)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

August 5, 2015

Mectron Spa c/o Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, 00153 ITALY

Re: K151023

Trade/Device Name: Compact Piezo LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: May 4, 2015 Received: May 7, 2015

Dear Mr. Roger 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.

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

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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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

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

## Indications for Use

510(k) Number (if known) K151023

Device Name COMPACT PIEZO LED

Indications for Use (Describe)

The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:

· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:

· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:

· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;

· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/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 and increase in size from left to right.

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 4.286.000 i.v. [e-mail]

# 510(k) Summary in accordance with 21 CFR 807.92 for Mectron Compact Piezo Led

### 1. ADMINISTRATIVE INFORMATION

| Type of 510(K) submission: | Traditional 510(k) Submission |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission date: | 4 August 2015 |
| 510(k) Submitter: | MECTRON S.p.a<br>Via Loreto 15<br>16042 Carasco - (GE) - ITALY<br>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<br>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 |
| | |
| Trade name of the device: | Compact Piezo Led |
| Common Name / Regulation Description: | Ultrasonic scaler |
| Regulation Number: | 21 CFR 872.4850 |
| Classification: | Class II |
| FDA Panel: | Dental |
| Product Code: | ELC |

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

Image /page/4/Picture/0 description: The image shows the logo for Mectron. The word "mectron" is written in orange, with the letters all connected. Below the word is a gray line with five gray circles of varying sizes along the line.

Mectron S Via Loreto, 15/A 16042 Carasco - GE (Italy) [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 4.286.000 i.v. [e-mail]

#### 3. PREDICATE DEVICES

The substantial equivalence of the Compact Piezo Led is based on the legally marketed predicate devices identified in Table 1:

#### Table 1: Predicate Devices

| Trade name | Predicate reference | Manufacturer | Product Code | 510(k) Number | Decision Date |
|-------------------|---------------------|---------------|--------------|---------------|---------------|
| Compact Piezo P2k | PD1 (primary) | Mectron S.p.a | ELC | K102218 | 01/24/2011 |
| Multipiezo | PD2 (reference) | Mectron S.p.a | ELC | K140965 | 08/20/2014 |

● The piezoelectric ultrasonic handpiece and the ultrasonic generator that are supplied with the subject device are identical/very similar to those described in the 510(k) submissions for these predicate devices.

. The tip inserts intended for use with the subject device were previously cleared by FDA within the 510(k)s of these predicate devices.

#### 4. DEVICE DESCRIPTION

The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.

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

The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.

The range of tip inserts, handpiece and torque wrench are autoclavable.

The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.

The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted through the dental unit's controls.

The ultrasonic generator of the Compact Piezo Led 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 ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip 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 Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.

The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

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

Image /page/5/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 the logo.

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 4.286.000 i.v. [e-mail]

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

The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:

- . Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits;
- . Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning;
- . Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;
- . Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

#### 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

Piezoelectric ultrasonic technology is used both by the subject and the predicate to generate mechanical micro-vibrations of the insert connected to the handpiece. The subject device and predicate devices share the same piezoelectric transducers, very similar ultrasonic generators, and same insert tips. Similarities and differences between the subject device and the predicate devices are summarized in Table 2.

| Description | Subject Device<br>Compact Piezo Led | Predicate Device 1 (PD1)<br>Compact Piezo P2K<br>Primary Predicate | Predicate Device 2 (PD2)<br>Multipiezo<br>Reference Predicate | Explanation of<br>differences<br>SE# |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| FDA panel | Dental | Dental | Dental | Identical to PD1 &<br>PD2 |
| Regulation #<br>and name | 872.4850 - Ultrasonic Scaler | 872.4850 - Ultrasonic Scaler | 872.4850 - Ultrasonic Scaler | Identical to PD1 &<br>PD2 |
| Product Code | ELC | ELC | ELC | Identical to PD1 &<br>PD2 |
| Classification | Class II | Class II | Class II | Identical to PD1 &<br>PD2 |
| Technological<br>Characteristics<br>(mechanism of<br>action) | Piezoelectric ultrasonic<br>technology that generates<br>mechanical micro-vibration of<br>the insert tips. The piezoelectric<br>transducer uses piezoceramic<br>disks to convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip. | Piezoelectric ultrasonic<br>technology that generates<br>mechanical micro-vibration of<br>the insert tips. The piezoelectric<br>transducer uses piezoceramic<br>disks to convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip. | Piezoelectric ultrasonic<br>technology that generates<br>mechanical micro-vibration of<br>the insert tips. The piezoelectric<br>transducer uses piezoceramic<br>disks to convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip. | Identical to PD1 &<br>PD2 |
| Device type | Sub-assembly device intended<br>to be incorporated into a dental<br>unit and/or table top device | Sub-assembly device intended<br>to be incorporated into a dental<br>unit and/or table top device | Table top device | Identical to PD1.<br>SE#1 |
| Description | Subject Device<br>Compact Piezo Led | Predicate Device 1 (PD1)<br>Compact Piezo P2K<br>Primary Predicate | Predicate Device 2 (PD2)<br>Multipiezo<br>Reference Predicate | Explanation of<br>differences<br>SE# |
| Indications for<br>use/Intended<br>use | The Compact Piezo Led is an<br>ultrasonic scaler intended for<br>use, with the appropriate<br>associated insert tips, in the<br>following dental applications:<br>· Scaling: Procedures for<br>removal of supragingival/<br>subgingival and interdental<br>calculus/plaque deposits;<br>· Periodontology: Periodontal<br>therapy and debridement for<br>periodontal diseases,<br>including periodontal pocket<br>irrigation and cleaning;<br>Endodontics: Treatments for<br>root canal reaming irrigation,<br>revision, filling, gutta-percha<br>condensation and<br>retrograde preparation;<br>· Restorative and Prosthetics:<br>Restorative procedures<br>including cavity preparation,<br>removal of prostheses,<br>amalgam condensation,<br>finishing of crown<br>preparations, inlay/onlay<br>condensation and<br>implants/restorations<br>cleaning. | The Compact Piezo P2K device<br>is an ultrasonic scaler intended<br>for use with the appropriate<br>associated insert tips, in the<br>following dental applications:<br>· Scaling: All general scaling<br>applications including<br>removal of supra/sub<br>gingival/ interdental<br>calculus/plaque deposits;<br>· Periodontology: Periodontal<br>therapy and debridement for<br>all types of periodontal<br>diseases, including<br>periodontal pocket irrigation<br>and cleaning;<br>Endodontics: All endodontics<br>procedures including<br>treatments for root canal<br>reaming, irrigation, revision,<br>filling, gutta-percha<br>condensation and<br>retrograde preparation;<br>· Restorative and Prosthetics:<br>All general restorative<br>procedures including cavity<br>preparation, removal of<br>prostheses, amalgam,<br>condensation and finishing<br>of crown preparation and<br>inlay/onlay condensation. | The Multipiezo Pro and<br>Multipiezo are piezoelectric<br>ultrasonic dental scalers<br>intended for use, with the<br>appropriate associated tip<br>inserts, in the following dental<br>applications:<br>· Scaling: All general<br>procedures for removal of<br>supragingival/subgingival<br>and interdental<br>calculus/plaque deposits;<br>· Periodontology: Periodontal<br>therapy and debridement for<br>all types of periodontal<br>diseases, including<br>periodontal pocket irrigation<br>and cleaning;<br>· Endodontics: All treatments<br>for root canal reaming,<br>irrigation, revision, filling,<br>gutta-percha condensation<br>and retrograde preparation;<br>Restorative and Prosthetics:<br>All general restorative<br>procedures including cavity<br>preparation, removal of<br>prostheses, amalgam<br>condensation, finishing of<br>crown preparations,<br>inlay/onlay condensation,<br>implants/restorations<br>cleaning. | Very similar to PD1<br>& PD2 |
| Transducer<br>Technological<br>characteristics | Piezoelectric: The transducer<br>uses four piezoceramic disks to<br>convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip | Piezoelectric: The transducer<br>uses four piezoceramic disks to<br>convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip | Piezoelectric: The transducer<br>uses four piezoceramic disks to<br>convert the generator's<br>electrical signal to ultrasonic<br>vibration of the insert tip | Identical to PD1 &<br>PD2 |
| Automatic<br>resonant<br>frequency tuning | Electronics with automatic<br>frequency tuning | Electronics with automatic<br>frequency tuning | Electronics with automatic<br>frequency tuning | Identical to PD1 &<br>PD2 |
| Led system<br>incorporated<br>inside the<br>handpiece to<br>provide<br>illumination of<br>the operative<br>site. | Yes | No | Yes | Identical to PD2.<br>SE#2 |
| Irrigation supply<br>source | Through irrigation line of the<br>dental unit where the Compact<br>Piezo Led is mounted. | Through irrigation line of the<br>dental unit where the Compact<br>Piezo P2K is mounted. | Two irrigation sources:<br>A refillable irrigation bottle<br>mounted on the console<br>connected to peristaltic pump,<br>or alternatively external water<br>supply by means of an optional<br>accessory. | Identical to PD1.<br>SE#3 |
| Description | Subject Device<br>Compact Piezo Led | Predicate Device 1 (PD1)<br>Compact Piezo P2K<br>Primary Predicate | Predicate Device 2 (PD2)<br>Multipiezo<br>Reference Predicate | Explanation of<br>differences<br>SE# |
| Irrigation flow<br>rate adjustment | Through the flow regulator of<br>the dental unit | Through the flow regulator of<br>the dental unit | Flow rate adjustable through the<br>touch panel of the console | Identical to PD1.<br>SE#4 |
| Feedback<br>system control | The power is automatically<br>adjusted as a function of the<br>resistance encountered by the<br>insert tip during the treatment. | The power is automatically<br>adjusted as a function of the<br>resistance encountered by the<br>insert tip during the treatment. | The power is automatically<br>adjusted as a function of the<br>resistance encountered by the<br>insert tip during the treatment. | Identical to PD1 &<br>PD2 |
| Supply Voltage | Powered through the dental<br>unit: 24 VAC ± 10% or 32 VDC<br>± 10%. | Powered through the dental<br>unit: 24 VAC ± 10% or 32 VDC<br>± 10%. | 100 - 240 VAC - 50/60 Hz | Identical to PD1.<br>SE#5 |
| Output<br>performance<br>specifications | Output: 15 Watt<br>Frequency range: 24 kHz to ~36<br>kHz | Output: 15 Watt<br>Frequency range: 24 kHz to<br>~36 kHz | Output: 15 Watt<br>Frequency range: 24 kHz to ~36<br>kHz | Identical to PD1 &<br>PD2 |
| Power Activation | Activation through the dental<br>unit | Activation through the dental<br>unit | Foot-pedal connected to the<br>control console by means of a<br>cord | Identical to PD1.<br>SE#6 |
| lectrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to PD1 &<br>PD2 |
| Electromagnetic<br>Compatibility | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Identical to PD1 &<br>PD2 |
| Does the device<br>contain<br>software? | Yes | Yes | Yes | Identical to PD1 &<br>PD2 |
| Differences in<br>Software | Softwa…