MT-Bone

K242432 · Mectron S.P.A. · DZI · Aug 19, 2024 · Dental

Device Facts

• Record ID: K242432
• Device Name: MT-Bone
• Applicant: Mectron S.P.A.
• Product Code: DZI · Dental
• Decision Date: Aug 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

MT-Bone 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

Tabletop piezoelectric ultrasonic surgical system; uses handpieces with piezoceramic disks to convert electrical signals into mechanical micro-vibrations (24-36 kHz) at insert tips. Used by clinicians for oral bone surgery (implantology, periodontal, orthodontic, endodontic) and dental scaling/restorative procedures. Provides selective cutting of mineralized tissue while minimizing trauma to soft tissues. Features touch screen interface, peristaltic irrigation pump, and wireless connectivity (IoT board). Clinician operates via footswitch; output is mechanical vibration of inserts for precise bone/tooth structure modification. Benefits include improved precision, reduced procedure time, and enhanced intraoperative usability compared to traditional macro-vibration methods (drills/saws).

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench performance testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), reprocessing validation, and comparative bench testing against the predicate device. Usability testing and cadaver lab evaluations confirmed performance, safety, and usability improvements.

Technological Characteristics

Piezoelectric ultrasonic transducer (piezoceramic disks); 24-36 kHz frequency; 10-250 μm vibration amplitude. Tabletop form factor; peristaltic irrigation pump. Connectivity: Wireless (ESP32 IoT board). Electrical safety: IEC 60601-1, IEC 80601-2-60. EMC: IEC 60601-1-2. Sterilization: Reusable handpieces/inserts validated for cleaning and sterilization.

Indications for Use

Indicated for infant, children, adolescent, and adult populations requiring oral bone surgery (cutting, osteotomy, osteoplasty, drilling) or dental scaling/periodontal/endodontic/restorative procedures. No specific contraindications listed.

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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August 19, 2024

Mectron S.p.A. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242432

Trade/Device Name: MT-Bone Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: August 15, 2024 Received: August 16, 2024

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K242432

Device Name

MT-Bone

Indications for Use (Describe)

MT-Bone 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)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a horizontal line and a series of gray circles below it. The contact information includes the company name, address (Via Loreto, 15/A, 16042 Carasco - GE, Italy), and telephone number ([phone]).

[phone]

medical technology www.mectron.com [e-mail]

## K242432

## Section: 510(k) Summary in accordance with 21 CRF 872.4120

Data: August 08, 2024

### 1. Administrative Information

| Type of 510(k) submission: | Traditional 3P 510(k) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Drill, Bone, Powered Scaler, Ultrasonic |
| Regulation description: | Bone cutting instrument and accessories |
| Proprietary names of the device: | MT-Bone |
| Manufacturer: | Mectron S.p.A.<br>Via Loreto, 15/a<br>Carasco - GE 16042, Italy |
| FDA Registration Number: | 3003933619 |
| 510(k) Owner: | Mectron S.p.A.<br>Via Loreto, 15/a<br>Carasco - GE 16042, Italy |
| 510(k) Preparer and Contact: | Ms. Chiara Acunzo<br>Regulatory Affairs Senior Specialist<br>Mectron S.p.A.<br>Telephone: [phone]<br>Cell: [phone]<br>Email: |

### Device identification: 2.

Regulatory Class: ............................Class II Classification Regulation: ....21 CFR 872.4120: Bone cutting instrument and accessories Product Codes: ....................................Primary [DZI] ..............................................................................................................................................................................

Review Panel: ..................................................Dental

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Image /page/4/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a horizontal line and a series of gray circles below it. The contact information includes the company name, address (Via Loreto, 15/A, 16042 Carasco - GE, Italy), and telephone number ([phone]).

hnology

### Identification of the Predicate / Reference Devices 3.

## Predicate device:

The Substantial Equivalence of the subject device is based on the predicate device.

| Trade Name | Manufacturer | Product Code | 510(k) Number |
|-----------------------|----------------|--------------|---------------|
| PIEZOSURGERY<br>TOUCH | Mectron S.p.A. | DZI, ELC | K122322 |

### Device description 4.

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery.

MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts.

This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces.

The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

### 5. Indications for Use

MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

- . Bone cutting, 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 & o plaque deposits;
- Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, O including periodontal pocket irrigation and cleaning;
- Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha O condensation and retrograde preparation;
- Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam O condensation, finishing of crown preparations and inlay/onlay condensation.

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Image /page/5/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo consists of the word "mectron" in orange, with a gray line and several gray circles underneath. The contact information includes the company's address, which is Via Loreto, 15/A, 16042 Carasco – GE (Italy), and their telephone number, which is [phone].

Fax [phone]

medical technology www.mectron.com [e-mail]

## 6. Comparison of the proposed device and the predicate device

A comparison of the subject device with the predicate device is shown in the following Table 1.1.

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Image /page/6/Picture/0 description: The image contains the word "mectron" in orange font. Below the word is a gray line with five gray circles of increasing size along the line. The circles are evenly spaced along the line.

medical technology

Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco - GE (Italy)

| | Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device | | | |
|----|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Item for comparison | MT-Bone<br>Subject Device | PIEZOSURGERY TOUCH<br>Predicate Device - K122322 | Identical / Different |
| 1 | Manufacturer | MECTRON SPA<br>Via Loreto 15/a<br>16042 Carasco - Italy | MECTRON SPA<br>Via Loreto 15/a<br>16042 Carasco - Italy | Identical to Predicate Device |
| 2 | 510(k) Number | Subject of this submission | K122322 | N/A |
| 3 | Regulation panel | Dental | Dental | Identical to Predicate Device |
| 4 | Regulation Number | 21 CFR 872.4120 | 21 CFR 872.4120 | Identical to Predicate Device |
| 5 | Product Code | Primary Product code: DZI (Bone Cutting Instrument And<br>Accessories<br>Subsequent Product Code: ELC Scaler, Ultrasonic | Primary Product code: DZI (Bone Cutting Instrument And<br>Accessories<br>Subsequent Product Code: ELC Scaler, Ultrasonic | Identical to Predicate Device |
| 6 | Classification | Class II | Class II | Identical to Predicate Device |
| 7 | Device type | Tabletop device | Tabletop device | Identical to Predicate Device |
| 8 | Function | MT-Bone is a surgical system that uses ultrasonic energy to<br>generate mechanical micro-vibration of associated inserts,<br>to perform cutting of bony structures in the procedures<br>defined by its intended use. | PIEZOSURGERY TOUCH is a surgical system that uses ultrasonic<br>energy to generate mechanical micro-vibration of associated<br>inserts, to perform cutting of bony structures in the procedures<br>defined by its intended use. | Similar to Predicate Device.<br>Optimized device setting for PIEZOSURGERY channel.<br>Dedicated channel for bone hole preparation addressed<br>to Implantology indication for use (PIEZODRILL<br>channel).<br>These differences do not impact safety or clinical<br>performance. |
| 9 | Indications for use | MT-Bone is a piezoelectric ultrasonic device, consisting of<br>handpieces and associated tip inserts, intended for:<br>• Bone cutting, osteotomy, osteoplasty and drilling in a<br>variety of oral surgical procedures, including | PIEZOSURGERY TOUCH is a piezoelectric ultrasonic device,<br>consisting of handpieces and associated tip inserts, intended for:<br>• Bone cutting, osteotomy, osteoplasty and drilling in a variety of<br>oral surgical procedures, including implantology, periodontal | Identical to Predicate Device |
| | Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device | | | |
| | Item for comparison | MT-Bone<br>Subject Device | PIEZOSURGERY TOUCH<br>Predicate Device - K122322 | Identical / Different |
| | | implantology, periodontal surgery, surgical orthodontic<br>and surgical endodontic procedures;<br>Scaling applications, including:<br>Scaling: All general procedures for removal of<br>supragingival and interdental calculus & plaque<br>deposits:<br>Periodontology: Periodontal therapy and<br>debridement for all types of periodontal diseases,<br>including periodontal pocket irrigation and cleaning;<br>Endodontics: All treatments for root canal reaming,<br>irrigation, revision, filling, gutta-percha condensation<br>and retrograde preparation;<br>Restorative and Prosthetics: Cavity preparation,<br>removal of prostheses, amalgam condensation,<br>finishing of crown preparations and inlay/onlay<br>condensation. | surgery, surgical orthodontic and surgical endodontic<br>procedures;<br>Scaling applications, including:<br>Scaling: All general procedures for removal of supragingival<br>and interdental calculus & plaque deposits;<br>Periodontology: Periodontal therapy and debridement for all<br>types of periodontal diseases, including periodontal pocket<br>irrigation and cleaning;<br>Endodontics: All treatments for root canal reaming, irrigation,<br>revision, filling, gutta-percha condensation and retrograde<br>preparation;<br>Restorative and Prosthetics: Cavity preparation, removal of<br>prostheses, amalgam condensation, finishing of crown<br>preparations and inlay/onlay condensation. | |
| 10 | Intended patient<br>population | Infant, children, adolescent, and adult population | Infant, children, adolescent, and adult population | Identical to Predicate Device |
| 11 | Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Identical to Predicate Device |
| 12 | Biocompatibility | Biocompatible | Biocompatible | Identical to Predicate Device |
| 13 | Parts need to be<br>sterilized prior use? | YES | YES | Identical to Predicate Device |
| 14 | Technological<br>Characteristics<br>(Mechanism of action) | Piezoelectric ultrasonic technology which generates<br>mechanical micro-vibrations of the insert tips. The<br>piezoelectric transducer uses piezoceramic disks to<br>convert the generator's electrical signal to ultrasonic<br>vibration of the insert tip. | Piezoelectric ultrasonic technology which generates mechanical<br>micro-vibrations of the insert tips. The piezoelectric transducer uses<br>piezoceramic disks to convert the generator's electrical signal to<br>ultrasonic vibration of the insert tip. | Identical to Predicate Device |
| 15 | Main Components of<br>the device | • Control unit with integrated irrigation peristaltic pump,<br>electric power supply and ultrasonic generator.<br>• PIEZOSURGERY MT and PIEZODRILL MT ultrasonic<br>handpieces and cord.<br>• Torque wrenches to tighten the inserts on the<br>handpiece.<br>• Footswitch with cord.<br>Bracket for irrigation solution bag.<br>• Power supply cord.<br>• Range of insert tips to be used according to the dental<br>applications defined by intented use.<br>• Other accessories (make reference to the "List of<br>Accessories" of the eSTAR submission) | • Control unit with integrated irrigation peristaltic pump, electric<br>power supply and ultrasonic generator.<br>• Piezosurgery ultrasonic handpiece and cord.<br>• Torque wrench to tighten the inserts on the handpiece.<br>• Footswitch with cord<br>• Bracket for irrigation solution bag.<br>• Power supply cord.<br>• Range of insert tips to be used according to the dental<br>applications defined by intented use.<br>Other accessories (make reference to the "List of Accessories"<br>of the eSTAR submission) | Similar to Predicate Device<br>This difference does not impact safety or clinical<br>performance |
| | Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device | | | |
| | Item for comparison | MT-Bone<br>Subject Device | PIEZOSURGERY TOUCH<br>Predicate Device - K122322 | Identical / Different |
| 16 | Interfaces<br>Handpieces | Two different piezoelectric handpieces can be connected<br>to the device control unit. Dedicated connectors and input<br>ports ensure correct connections. Both handpieces encase<br>piezoelectric transducers responsible for generation and<br>transmission of micrometric vibrations to the insert tips<br>connected at ultrasonic frequencies.<br>- PIEZOSURGERY MT handpiece is intended for all the<br>claimed indications for use of the device;<br>PIEZODRILL MT handpiece is dedicated to implant site<br>preparation. Its usage in conjunction with dedicated insert<br>tips allows the precise, efficient and safe drilling of holes of<br>different diameters and depths within hard mineralized<br>tissue | One piezoelectric handpiece can be connected to the device<br>control unit. PIEZOSURGERY TOUCH handpiece, and all claimed<br>indications for use of the device can be performed using it." | Similar to Predicate Device.<br>PIEZOSURGERY MT handpiece comprises exactly the<br>same piezozelectric transducer of the<br>PIEZOSURGERY TOUCH handpiece and can perform<br>all the indications for use claimed by the<br>PIEZOSURGERY TOUCH device. The PIEZODRILL<br>MT handpiece comprises a piezoelectric transducer<br>specifically designed to allow more efficient bone<br>drilling when used in conjunction with dedicated insert<br>tips. Optimized with I higher efficiency of the former, as<br>a consequence of improved drilling efficiency and<br>intraoperative usability.<br>These differences do not impact safety or clinical<br>performance. |
| 17 | Interfaces<br>Footswitch | Footswitch connected to the control console by means of a<br>cord | Footswitch connected to the control console by means of a cord | Identical to Predicate Device |
| 18 | Irrigation System | Irrigation bag connected to a peristaltic pump. Adjustable<br>irrigation flow rate. | Irrigation bag connected to a peristaltic pump. Adjustable irrigation<br>flow rate. | Identical to Predicate Device |
| 19 | Ultrasound Frequency | 24 kHz to~36 kHz | 24 kHz to~36 kHz | Identical to Predicate Device |
| 20 | Vibration amplitude | $10 \mu m + 250 \mu m$ | $10 \mu m + 250 \mu m$ | Identical to Predicate Device |
| 21 | Electrical power input | 100-240 V ~ 50/60 Hz | 100 - 240 V - 50/60 Hz. | Identical to Predicate Device |
| 22 | Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to Predicate Device |
| 23 | Electromagnetic<br>Compatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to Predicate Device…