turbodent touch

K251425 · Mectron S.P.A. · KOJ · May 9, 2025 · Dental

Device Facts

• Record ID: K251425
• Device Name: turbodent touch
• Applicant: Mectron S.P.A.
• Product Code: KOJ · Dental
• Decision Date: May 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. turbodent touch is intended for the following oral prophylaxis procedures: - Plaque removal for placement of sealants - Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers - Surface preparation prior to placing composite restorations - Effective plaque and stain removal for orthodontic patients - Cleaning prior to bonding ortho brackets - Cleaning implant fixtures prior to loading - Stain removal for shade determination - Plaque removal prior to fluoride treatment - Plaque and stain removal prior to whitening procedures The turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. The turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Device Story

Tabletop air-polishing unit; uses compressed air to project water and dental prophylaxis powder onto tooth surfaces. Kinetic energy of powder particles removes plaque, soft deposits, and stains; water jet provides continuous washing and prevents powder dissemination. Operated by dental professionals in clinical settings via touch-screen interface and foot pedal. Features two removable powder tanks (PROPHY and PERIO channels) and three handpieces (90°, 120°, and PERIO). Connects to external water network. Output is mechanical cleaning of dental surfaces. Benefits include effective plaque/stain removal, surface preparation for restorative/orthodontic procedures, and non-surgical periodontal debridement. Device is a functionally segmented version of the combi touch (K231391), retaining air-polishing functionality while removing ultrasonic scaling components.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), software validation (IEC 62304), performance testing (treatment effectiveness, powder consumption, clogging, water temperature), usability testing, and distribution/transit simulation (ASTM D4169).

Technological Characteristics

Tabletop air-polishing unit. Principle: mechanical action of pressurized air/water/powder jet. Components: console, foot pedal, water/air hoses, three handpieces (90°, 120°, PERIO). Power: 100-240V, 50/60Hz. Connectivity: external water network. Software: embedded firmware. Biocompatibility: ISO 10993-1 compliant. Electrical safety: IEC 60601-1, IEC 80601-2-60. EMC: IEC 60601-1-2.

Indications for Use

Indicated for patients >2 years old, including children, adolescents, adults, and seniors, for supra-gingival and sub-gingival prophylaxis. Procedures include plaque/stain removal, surface preparation for bonding/restorations, orthodontic cleaning, implant cleaning, and periodontal maintenance (subgingival plaque removal in pockets up to 5 mm).

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Predicate Devices

• combi touch (K231391)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 9, 2025

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

Re: K251425
Trade/Device Name: turbodent touch
Regulation Number: 21 CFR 872.6080
Regulation Name: Airbrush
Regulatory Class: Class II
Product Code: KOJ, ELC
Dated: May 8, 2025
Received: May 8, 2025

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251425 - Prithul Bom
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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

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K251425 - Prithul Bom
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251425 | |
| Device Name turbodent touch | |
| Indications for Use (Describe) | |
| turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. turbodent touch is intended for the following oral prophylaxis procedures: - Plaque removal for placement of sealants - Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers - Surface preparation prior to placing composite restorations - Effective plaque and stain removal for orthodontic patients - Cleaning prior to bonding ortho brackets - Cleaning implant fixtures prior to loading - Stain removal for shade determination - Plaque removal prior to fluoride treatment - Plaque and stain removal prior to whitening procedures | |
| The turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. The turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. | |
| 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) | |
| 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 [e-mail] | |
| "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." | |

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K251425

metron

Medicoat of the National Institute of Mental Health

Medical technology

Medtron S.p.A.

Società a socio unico

Via Loreto, 15/A

16042 Carasco - GE (Italy)

Tel. [phone]

Fax [phone]

www.mectron.com

[e-mail]

# electronic Submission Template And Resource (eSTAR)

# Section: 510(k) Summary

## 1. Administrative Information

| Type of 510(k) submission | Traditional 3P 510(k) |
| --- | --- |
| Manufacturer and 510(k) Owner | Mectron S.p.A.
Via Loreto, 15/A
Carasco - GE 16042, Italy |
| FDA Registration Number | 3003933619 |
| 510(k) Submission and Contact | Chiara Acunzo
Design Quality Manager
Mectron S.p.A.
Telephone: [phone]
Cell: [phone]
Email: [e-mail] |
| Data Prepared | April 18th, 2025 |

## 2. Device identification

| Proprietary Name | turbodent touch |
| --- | --- |
| Common/Usual Name | Air Polishing Unit |
| Classification Name | Airbrush (21 CFR 872.6080) |
| Device Class | II |
| Product Code | KOJ |

## 3. Identification of the Predicate / Reference Devices

### Predicate device:

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

| Trade Name | Manufacturer | Product Code | 510(k) Number |
| --- | --- | --- | --- |
| combi touch | Mectron S.p.A. | ELC, KOJ | K231391 |

### Reference device:

No reference devices were used in this submission.

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00

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mectron

Medicoi Technology

Mectron S.p.A.

Società a socio unico

Via Loreto, 15/A

16042 Carasco – GE (Italy)

Tel. [phone]

Fax [phone]

www.mectron.com

[e-mail]

## 4. Device description

turbodent touch can be considered a functionally segmented version of the combi touch device (K231391), incorporating exclusively the air polishing functionality. It shares the main components, materials, and manufacturing processes as the combi touch, from which it is derived. The indication for use of turbodent touch is aligned with the air polishing indication of the combi touch.

The turbodent touch uses an operating principle based on the mechanical action of an accelerated powder jet, obtained thanks to compressed air. The kinetic energy imparted to the particles is almost completely dissipated in the impact against the dental surface, producing a delicate but effective cleaning action. The action is completed by a jet of water which, taking advantage of the depression created around the nozzle, is arranged in a bell-like shape surrounding the air and powder mixed flow. The water flow produces a double effect: continuous washing of the area treated from excess powder, and prevention of environmental dissemination of the powder in the operating area.

In detail, the turbodent touch is mainly based on one polisher channel and it is equipped with three handpieces, AIR-POLISHING 90°, AIR-POLISHING 120° AND AIR-POLISHING PERIO (handpieces are already cleared, K231391). The device has a touch keyboard, displaying all selectable functions and the value scales that can be set by the user by simply gently pressing the finger at the chosen buttons.

The user-configurable settings include depressurization of the powder containers for safe removal, no powder cleaning mode and consequently the possibility of excluding water as well, circuit filling/rinsing, and air-polishing modes. For each selected air-polishing mode (PROPHY or PERIO), it is possible to choose different power levels (LOW, MEDIUM and HIGH) within a certain range preset by the manufacturer. The air-polishing action is activated by means of a foot pedal.

The irrigation system is completely external with irrigation tubing connecting the handpiece to the machine that has a connection to the external water network.

The turbodent touch is not intended to interact with other devices during use. About patient interaction, the SUBGINGIVAL PERIO TIPS (already cleared, K231391) attached to the terminal part of the handpiece AIR-POLISHING PERIO, enter into direct contact with the patient's body during use to allow the intended therapeutic functions to take place. These medical devices are supplied sterile and certified by external suppliers. Possible contact of the patient with the external part of the handpiece must be considered in the evaluation.

The production processes carried out internally at Mectron for processing the components of turbodent touch system are mainly assembly processes according to specific workflows and a dedicated production line.

## 5. Indications for Use

turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

turbodent touch is intended for the following oral prophylaxis procedures:

- Plaque removal for placement of sealants
- Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
- Surface preparation prior to placing composite restorations
- Effective plaque and stain removal for orthodontic patients
- Cleaning prior to bonding ortho brackets

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00

{6}

mectron

Medcon S.p.A.
Società a socio unico
Via Loreto, 15/A
16042 Carasco – GE (Italy)
Tel. [phone]
Fax [phone]

medical technology

www.mectron.com
[e-mail]

- Cleaning implant fixtures prior to loading
- Stain removal for shade determination
- Plaque removal prior to fluoride treatment
- Plaque and stain removal prior to whitening procedures

turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

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

A side-by-side comparison of the predicate device and the proposed devices is provided in Table 1 on the following page.

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00
Page 3 of 9

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mectron medical technology

Electron S.p.A.

Via Loreto, 15/A - 16042 Carasco - GE (Italy)

Table 1. Comparison Table for determination of Substantial

| Item for Comparison | turbodent touch
Proposed Device | combi touch
Predicate Device- K231391 | Variations |
| --- | --- | --- | --- |
| Manufacturer | MECTRON SPA
Via Loreto 15/A
16042 Carasco - Italy | MECTRON SPA
Via Loreto 15/A
16042 Carasco - Italy | Identical |
| 510(k) Number | Subject of this submission | K231391 | N/A |
| Product Code | KOJ | Primary Product code: ELC
Subsequent Product Code: KOJ | Identical for code KOJ |
| Regulation Panel | Dental | Dental | Identical |
| Classification | Class II | Class II | Identical |
| Combination Product | No | No | Identical |
| Device type | Table top device | Table top device | Identical |
| Function | Air-polishing | Ultrasonic scaling and Air-polishing | Identical for Air-polishing function |
| Indications for use | turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. | combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.
Ultrasonic scaler function:
combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications: | Identical for Air-polishing prophylaxis function |

Electronic Submission Template And Resource (eSTAR) - turbodent touch Rev.00

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mectron medical technology

Mectron S.p.A.

Via Loreto, 15/A - 16042 Carasco - GE (Italy)

| Item for Comparison | turbodent touch
Proposed Device | combi touch
Predicate Device- K231391 | Variations |
| --- | --- | --- | --- |
| | turbodent touch is intended for the following oral prophylaxis procedures:
- Plaque removal for placement of sealants
- Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
- Surface preparation prior to placing composite restorations
- Effective plaque and stain removal for orthodontic patients
- Cleaning prior to bonding ortho brackets
- Cleaning implant fixtures prior to loading
- Stain removal for shade determination
- Plaque removal prior to fluoride treatment
- Plaque and stain removal prior to whitening procedures

The turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. The turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. | • Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cleaning restorations and implant surfaces

**Air-polishing prophylaxis function:**
By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.
The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.
combi touch is intended for the following oral prophylaxis procedures:
• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixture prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedure

The combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease.
The combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. | |

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00
Page 5 of 9

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

| Item for Comparison | turbodent touch
Proposed Device | combi touch
Predicate Device- K231391 | Variations |
| --- | --- | --- | --- |
| Anatomical Site and contact tissues | Oral cavity - Teeth and soft tissues | Oral cavity - Teeth and soft tissues | Identical |
| Intended patient population | Children;
Adolescents;
Adults;
Seniors.
This medical device can be used on patients of any weight, height, sex or nationality, and who are over 2 years of age. | Children;
Adolescents;
Adults;
Seniors.
This medical device can be used on patients of any age, weight, height, gender, and nationality, where applicable. | Identical for patient categories |
| Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Sterility | Not sterile. | Not sterile. | Identical |
| Technological Characteristics (Mechanism of action) | **Air-polishing prophylaxis function:**
It is based on the principle of projecting a pressurized air mixed with water and a prophylaxis powder on the treatment site. | **Ultrasonic Scaler Function:**
Piezoelectric ultrasonic technology that generates mechanical micro-vibration of the insert tips.
The piezoelectric transducer uses piezoceramic disks to convert the generator's electrical signal to ultrasonic vibration of the insert tip.

**Air-polishing prophylaxis function:**
It is based on the principle of projecting a pressurized air mixed with water and a prophylaxis powder on the treatment site. | Identical for Air-polishing prophylaxis function |
| Main Items | - Device console
- Pedal FS-11 with cord and plug
- Water supply hose with quick coupling
- Air supply hose with quick coupling
- Water filter
- turbodent touch o-ring kit
- Water circuit disinfection kit
- Cleaning needle kit
- AIR-POLISHING 120° handpiece
- AIR-POLISHING PERIO handpiece
- AIR-POLISHING 90° handpiece
- SUBGINGIVAL PERIO TIPS
- K9 wrench | - Device console.
- Pedal FS-05 with cord and plug
- Water supply hose with quick coupling
- Air supply hose with quick coupling
- Water filter
- combi touch o-ring kit
- Water circuit disinfection kit
- Cleaning needle kit
- AIR-POLISHING 120° handpiece
- AIR-POLISHING PERIO handpiece
- AIR-POLISHING 90° handpiece
- SUBGINGIVAL PERIO TIPS
- K9 wrench | Identical for Air-polishing part.
For foot-pedal no design and safety differences between FS-05 e FS-11. |

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00
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metron

medical technology

Mectron S.p.A.

Via Loreto, 15/A - 16042 Carasco - GE (Italy)

| Item for Comparison | turbodent touch
Proposed Device | combi touch
Predicate Device- K231391 | Variations |
| --- | --- | --- | --- |
| | • Black power supply cable | • Black power supply cable
• SLIM Scaler Handpiece
• Ultrasonic scaling inserts
• Irrigation tank complete with cap | |
| Prophylaxis powder tanks | Two separated and removable powder tanks, both housed in the casing of the device's console.
One tank is dedicated to being used for the supragingival treatments (PROPHY channel).
One tank is dedicated to being used for the subgingival treatments (PERIO channel).
Both powder tanks are always available to be used according to the treatment selected from the end user on the console's touch panel. | Two separated and removable powder tanks, both housed in the casing of the device's console.
One tank is dedicated to being used for the supragingival treatments (PROPHY channel).
One tank is dedicated to being used for the subgingival treatments (PERIO channel).
Both powder tanks are always available to be used according to the treatment selected from the end user on the console's touch panel. | Identical |
| User Interface | Touch screen keypad | Touch screen keypad | Identical |
| Device contains Software | YES | YES | Identical |
| Electrical Safety | Complies with:
• IEC 60601-1
• IEC 80601-2-60 | Complies with:
• IEC 60601-1
• IEC 80601-2-60 | Identical |
| Electromagnetic compatibility | Complies with:
• IEC 60601-1-2 | Complies with:
• IEC 60601-1-2 | Identical |
| Power supply voltage | 100-240 V ~ 50/60 Hz | 100-240 V ~ 50/60 Hz | Identical |
| Maximum absorbed power | 90 VA | 90 VA | Identical |
| Air supply | Input pressure: between 4.5 and 8 bar
Operating pressure:
Prophy function: 2.5 - 3.5 bar
Perio function: 1.9 – 2.7 bar | Input pressure: between 4 and 8 bar
Operating pressure:
Prophy function: 3.5 bar
Perio function: 2.7 bar | Identical for high power settings |
| Dimensions:
(HxWxD) | 145 x 260 x 310 mm | 145 x 260 x 410 mm | Identical for air-polishing part (console + handpiece holder). The difference is due to the removal of the scaler part. |
| Weight (approx) | 4,2 Kg | 4,8 Kg | |

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00
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mectron

Medical technology

Mectron S.p.A.

Società a socio unico

Via Loreto, 15/A

16042 Carasco - GE (Italy)

Tel. [phone]

Fax [phone]

www.mectron.com

[e-mail]

# 7. Substantial Equivalence Discussion

The proposed device and the predicate device have a substantially identical intended use.

The proposed device and the predicate device share also many identical features and components, including identical/equivalent principle of operation and technological characteristics, as well as shared parts.

The differences identified in the above table 1 clearly have no impact on the safety or effectiveness of the device. Any differences identified in the above table do not introduce any new questions regarding safety and effectiveness.

# 8. Summary of Non-Clinical Testing

The following table summarizes the relevant bench performance testing concluded on the turbodent touch system.

| Bench performance testing category | Test description |
| --- | --- |
| Electrical safety | The device was positively tested according to, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD1:2012/AMD2:2020, IEC 80601-2-60:2019 for electrical safety.
According to the results and evidence reported within test report the device turbodent touch is considered electrically safe. |
| EMC | The device was positively tested according to IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 for electromagnetic compatibility.
According to the results and evidence reported within test report the device turbodent touch has demonstrated electromagnetic compatibility. |
| Biocompatibility | The device was positively tested according to ISO 10993-1 and FDA guidance Use of International Standard ISO 10993-1.
The Biological Evaluation Plan and Report summarize the endpoints identified for the device according to its intended use (time and type of contact).
All tests were passed successfully.
The testing showed that the relevant parts of the subject devices are biocompatible. |
| Software and Firmware | The software used in the various modules embedded within the devices was developed and positively validated according to:
• IEC 62304+A1.
• The FDA guidance "Content of Premarket Submissions for Device Software Functions"
• The requirements of clause 14 of IEC60601-1 3.2 edition.
• The requirements of IEC 60601-1-4+A1 (identical to the International Standard IEC 60601-1-4+A1), for the countries in which the standard is valid. |
| Performance Testing – Bench | A series of tests evaluated the treatment effectiveness and safety of the turbodent touch device in combination with prophylaxis powders, the effective powder consumption, the risk of clogging events, and the water temperature from the handpiece verification. |
| Usability Testing | The usability tests included:
- simulation of the installation, configuration and assembly of the device in accordance with the user manual.
- Understanding of the user interface.
- Clinical procedures evaluation for what regards the new power settings of PERIO and PROPHY modes and the new no powder mode. |

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00

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mectron

Medical technology

Mectron S.p.A.

Società a socio unico

Via Loreto, 15/A

16042 Carasco - GE (Italy)

Tel. [phone]

Fax [phone]

www.mectron.com

[e-mail]

| Bench performance testing category | Test description |
| --- | --- |
| | The usability tests were passed successfully. Analyzing all the KOLs feedback and evaluations, the usability of the device results validated according to the test objectives.
Furthermore, the validation in terms of clinical procedures highlights a well-perceived performance of all power settings and modes. |
| Distribution testing | Transit simulation (according to ASTM D4169), and subsequent electrical safety verification were done on the device system configuration.
All the controls on the components after the tests performed in external laboratories were conducted and all the items worked properly.
Electrical safety tests, done internally by V&V department, resulted in measurements within the acceptable ranges.
To conclude, all tests are considered successfully passed, so the packaging of the device is compliant with all relative standards that specify the transportation rules. |

# 9. Summary of Clinical Testing

No clinical testing was conducted for this submission.

# 10. Summary of Other Information

No other information is available.

# 11. Conclusion

Based on the information and supporting documentation provided in the premarket notification turbodent touch is substantially equivalent to the identified predicate device combi touch.

Electronic Submission Template And Resource (eSTAR) – turbodent touch Rev.00