Combi Touch

K231391 · Mectron S.P.A. · ELC · May 15, 2023 · Dental

Device Facts

• Record ID: K231391
• Device Name: Combi Touch
• Applicant: Mectron S.P.A.
• Product Code: ELC · Dental
• Decision Date: May 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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: - 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 supragingival 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 fixtures prior to loading - Stain removal for shade determination - Plaque removal prior to fluoride treatment - Plaque and stain removal prior to whitening procedures combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Device Story

Combi Touch is a table-top dental device combining a piezoelectric ultrasonic scaler and an air-polishing prophylaxis unit. The scaler uses piezoceramic transducers to convert electrical signals into mechanical micro-vibrations of insert tips for calculus removal, periodontal debridement, and endodontic procedures. The air-polisher projects a mixture of compressed air, water, and dental prophylaxis powders (sodium bicarbonate or glycine) onto tooth surfaces to remove plaque and stains. The device features an automatic tuning circuit to maintain scaling efficiency despite tip wear. It is operated by dental professionals in a clinical setting using a foot pedal and console touch panel. The device connects to external water supplies or uses an integrated irrigation tank. Output is delivered via specialized handpieces (ultrasonic or air-polishing). The device benefits patients by providing comprehensive prophylaxis and periodontal maintenance in a single unit, reducing the need for multiple devices.

Clinical Evidence

No clinical data. Bench testing only. Performance testing verified effectiveness in plaque removal, surface morphology integrity, and erosion rates compared to the predicate device.

Technological Characteristics

Piezoelectric ultrasonic technology (24-36 kHz); air-polishing via pressurized air/water/powder projection. Materials: stainless steel, diamond/titanium nitride coatings, PEEK, EVA, LPDE, Viton, PPSU, TPX. Connectivity: standalone table-top unit with foot pedal. Sterilization: steam autoclaving for reusable handpieces/tips; subgingival perio tips are sterile single-use. Software: embedded control system with automatic tuning.

Indications for Use

Indicated for dental patients requiring supra/subgingival calculus/stain removal, periodontal therapy/debridement, root planing, endodontic irrigation, cavity preparation, and restoration/implant cleaning. Also indicated for oral prophylaxis (plaque/stain removal) and non-surgical subgingival plaque removal in periodontal pockets up to 5 mm.

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

• EMS AIR FLOW PROPHYLAXIS MASTER (K190124)

Reference Devices

• MULTIPIEZO (K140965)

Submission Summary (Full Text)

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May 15, 2023

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

Re: K231391

Trade/Device Name: Combi Touch Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: Class II Product Code: ELC, KOJ Dated: May 12, 2023 Received: May 12, 2023

### 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, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K231391

Device Name

combi touch

Indications for Use (Describe)

combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an airpolishing 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:

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

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi 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)

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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 includes the word "mectron" in orange. The contact information includes the address "Via Loreto, 15/A, 16042 Carasco - GE (Italy)", the telephone number "[phone]", and the fax number "[phone]".

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

# electronic Submission Template And Resource (eSTAR)

# Section: 510(k) Summary in accordance with 21 CRF 807.92

April 18, 2023

### 1. Administrative Information

| Type of 510(k) submission: | Premarket Notification |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Ultrasonic scaler/Air Polishing unit |
| Regulation description: | Ultrasonic scaler |
| Proprietary names of the device: | combi touch |
| 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: | Mr. Edoardo Tronchet<br>Regulatory Affairs Manager<br>Mectron S.p.A.<br>Telephone: [phone]<br>Cell: [phone] |

Email: [e-mail]

#### 2. Device identification:

Regulatory Class: ...................................Class II Classification Regulation:....21 CFR 872.4850: Ultrasonic Scaler Product Codes: ............................................................................................................................................................... .............................................................................................................................................................................. Review Panel: ........................................Dental

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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 features the word "mectron" in orange, with a gray line and circles underneath. The contact information includes the address Via Loreto, 15/A, 16042 Carasco - GE (Italy), as well as the telephone number [phone] and fax number [phone].

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

#### 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 |
|---------------------------------------|------------------------------|--------------|---------------|
| EMS AIR FLOW<br>PROPHYLAXIS<br>MASTER | EMS (Electro Medical System) | ELC, KOJ | K190124 |

### Reference device:

For the Substantial Equivalence we have also considered the reference device:

| Trade Name | Manufacturer | Product Code | 510(k) Number |
|------------|--------------|---------------|---------------|
| MULTIPIEZO | MECTRON Spa | ELC, EFB, EJR | K140965 |

#### Device description 4.

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

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Image /page/6/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 gray line and dots underneath. The contact information includes the address "Via Loreto, 15/A, 16042 Carasco - GE (Italy)", as well as the telephone number "[phone]" and fax number "[phone]".

dical technology [e-mail]

#### 5. Indications for use

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:

- 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.

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Image /page/7/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 gray line and circles underneath. The contact information includes the address, Via Loreto, 15/A, 16042 Carasco - GE (Italy), as well as the telephone number [phone] and fax number [phone].

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

The combi 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 / reference devices

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

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Image /page/8/Picture/0 description: The image shows the word "mectron" in orange font. To the left of the word is a blue vertical bar. Below the word are six gray circles arranged in two rows of three.

| | Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Item for<br>comparison | COMBI TOUCH<br>Subject Device | EMS AIRFLOW PROPHYLAXIS MASTER<br>Primary Predicate Device - PD1 - K190124 | MULTIPIEZO<br>Reference Device - RD - K140965 | Variations |
| 1 | Manufacturer | MECTRON SPA<br>Via Loreto 15/A<br>16042 Carasco - Italy | E.M.S. ELECTRO MEDICAL SYSTEMS S.A.<br>31 Ch. de la Vuarpilliere<br>Nyon Vaud, SWITZERLAND CH-1260 | MECTRON SPA<br>Via Loreto 15/A<br>16042 Carasco - Italy | N/A |
| 2 | 510(k) Number | Subject of this submission | K190124 | K140965 | N/A |
| 3 | Regulation<br>panel | Dental | Dental | Dental | Identical to PD1 & RD |
| 4 | Regulation<br>Number | 21 CFR 872.4850 | 21 CFR 872.4850 | 21 CFR 872.4850 | Identical to PD1 & RD |
| 5 | Common/Usual<br>name and<br>function | Ultrasonic scaler/Air Polishing unit | Ultrasonic scaler/Air Polishing unit | Ultrasonic scaler | Identical to PD1<br>Identical to RD for the<br>ultrasonic scaler function |
| 6 | Product Code | Primary Product code: ELC<br>Subsequent Product Code: KOJ | Primary Product code: ELC<br>Subsequent Product Code: KOJ; | ELC | Identical to PD1<br>Identical to RD for code<br>ELC |
| 7 | Classification | Class II | Class II | Class II | Identical to PD1 & RD |
| 8 | Combination<br>Product | No | No | No | Identical to PD1 & RD |
| 9 | Device type | Table top device…