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 fixtures prior to loading
Stain removal for shade determination
Plaque removal prior to fluoride treatment
Plaque and stain removal prior to whitening procedure

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 Description

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.

AI/ML Overview

The provided documentation describes the acceptance criteria and a study demonstrating that the Mectron S.p.A. "Combi Touch" device meets these criteria. The device is an ultrasonic scaler and air-polishing prophylaxis unit.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the comparison to the predicate device and the adherence to various non-clinical performance standards. The "reported device performance" is essentially that the "combi touch" meets or is comparable to the predicate device in all measured aspects and complies with the listed standards.

Item for Comparison	COMBI TOUCH (Subject Device)	EMS AIRFLOW PROPHYLAXIS MASTER (Predicate Device - K190124)	MULTIPIEZO (Reference Device - K140965)	Acceptance Criteria / Indication of Performance
Intended Use	Ultrasonic scaler function: removing calculus, periodontal therapy, scaling, root planing, releasing crowns, condensing gutta percha, amalgam condensation/burnishing, root canal prep/cleaning/irrigating, cavity prep, cleaning restorations/implants. Air-polishing function: complete supra- and sub-gingival prophylaxis (plaque/stain removal for sealants, surface prep before bonding, orthodontic patients, implant fixtures, shade determination, fluoride treatment, whitening procedures). Non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment.	Ultrasonic scaler function: removing calculus, periodontal pocket lavage, scaling, root planning, releasing crowns, condensing gutta percha, amalgam condensation/burnishing, root canal prep/cleaning/irrigating, cavity prep, cementing inlays/onlays, retrograde prep of root canals. Air-polishing function: cleaning/polishing of teeth (plaque/stain/soft deposit removal). Non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment.	Piezoelectric ultrasonic dental scaler for: Scaling (supra/subgingival, interdental calculus/plaque). Periodontology (periodontal therapy, debridement, pocket irrigation). Endodontics (root canal reaming, irrigation, revision, filling, gutta-percha condensation, retrograde prep). Restorative/Prosthetics (cavity prep, prosthesis removal, amalgam condensation, crown prep finishing, inlay/onlay condensation, implants/restorations cleaning).	Similar to PD1 (except for cementing inlays and onlays which Combi Touch cannot perform). Similar to RD for ultrasonic scaler function. The device is considered substantially equivalent for its intended use.
Technological Characteristics	Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks). Air-polishing: pressurized air mixed with water and powder projected onto tooth surface.	Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks). Air-polishing: pressurized air mixed with water and powder projected onto tooth surface.	Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks).	Similar to PD1 and RD for ultrasonic scaler function. No new questions regarding safety or effectiveness.
Biocompatibility	Biocompatible (materials in direct contact with patient: Stainless steel, Diamond coating, Titanium nitride coating, PEEK, EVA+LPDE, Viton, PPSU, TPX).	Biocompatible (materials in direct contact with patient: Stainless steel, Titanium, COC, PPSU, EPDM, PEEK, Hytrel SC969).	Biocompatible (materials in direct contact with patient: Stainless steel, Diamond coating, Titanium nitride coating, PEEK).	Biocompatible; Similar to PD1 & RD. Differences in materials do not impact safety or performance.
Prophylaxis Powders Used	Sodium Bicarbonate based powder, Glycine based powder.	PERIO (Glycine), SOFT (Glycine), CLASSIC (Sodium Bicarbonate), PLUS (Erythritol).	N/A	Tests demonstrated effective plaque removal and no dental surface damage, with erosion comparable to or lower than the predicate device. This indicates the powders are effective and safe for their intended use.
Non-Clinical Standards Compliance	Complies with: CEI UNI EN ISO 14971:2019, ISO/TR 24971:2020, IEC 60601-1:2015, AMD1:2012, IEC 60601-1-2:2014; Amendment 1:2020, IEC 60601-1-6:2010 Amendment 1:2013, IEC 62366: 2007/AMD1:2014, IEC 62304:2006 + AMD1:2015, ASTM D4169-16, ISO 7153-1:2016, ASTM F899-20, ASTM F136-13, EN 10088-3:2014, EN ISO 11737-1:2018/AMD 1:2021, EN ISO 11737-2:2020, EN 62353:2015, IEC 62471:2006, EN 62471:2008, IEC 80601-2-60:2019, ISO 10993-1:2018, UNI EN ISO 10993-5:2009, UNI EN ISO 10993-7:2008, ISO 10993-10:2021, ISO 10933-11:2017, ISO 10993-12:2021, ISO 11607-1:2019, ISO 11607-2:2019, UNI EN 1422:2014, EN ISO 15223-1:2021, UNI 556-1:2002/AC:2006, AAMI ST77:2013/®:2018, AAMI ST79:2017, AAMI ST8:2013, ISO 15883-1:2007, ISO/TS 15883-5:2005, ISO 15883-5:2021, AAMI TIR12:2010, AAMI TIR28:2016, AAMI TIR30:2011 (R2016), ISO 17664-1:2021, EN ISO 15883-4:2018, ASTM E1837-96 (Reapproved 2014), AFNOR NF T 72-281, 2014, EN 1276:2019, EN ISO 11135:2014/A1:2019, ISO 11138-1:2017, ISO 11138-2:2017, ISO 11138-3:2017, ISO 11138-7:2017, EN ISO 11737-1:2015, EN ISO 11737-2:2020, UNI EN 868-2:2009, ISO 17665-1:2006, AAMI/ISO TIR 17665-2:2009, EN ISO 5349-1:2001, ISTA 2A :2011, UNI EN ISO 5349-2:2015, EN ISO 20417:2021.	Complies with relevant FDA-recognized standards.	Complies with relevant FDA-recognized standards.	Compliance with all listed non-clinical standards. This ensures the device's basic safety and performance according to established benchmarks.

Study Proving Acceptance Criteria:

The documentation states that:

"The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States."

And critically, regarding performance testing:

"The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above: 1) was effective in the removal of simulated plaque from dental surfaces. 2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment; 3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices." This implies that the testing for the "Combi Touch" device focused on non-clinical performance and engineering standard compliance rather than a traditional clinical study with patient data.

Sample Size for Test Set: Not specified for any clinical data. For the non-clinical performance involving "simulated plaque from dental surfaces" and "examination of tooth surfaces morphology," the specific sample size of tested dental surfaces or teeth is not provided within this document.
Data Provenance: Not specified, as it's primarily non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this was not a clinical study involving human ground truth assessment. The assessment of "simulated plaque" and "tooth surfaces morphology" would likely involve expert evaluation, but the number and qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasonic scaler/air-polisher, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device does not feature an AI algorithm for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests mentioned (plaque removal, dental surface damage/erosion), the ground truth appears to be based on:

Objective measurements of simulated plaque removal.
Laboratory examination of tooth surface morphology (e.g., microscopy) to assess damage/erosion after treatment.
Comparison against the performance of the predicate device under similar testing conditions.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a 'training set.'

9. How the ground truth for the training set was established

Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

{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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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

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.

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

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.

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

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."

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

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 "+39 0185 35361", and the fax number "+39 0185 351374".

medical technology www.mectron.com mectron@mectron.com

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.Via Loreto, 15/aCarasco - GE 16042, Italy
FDA Registration Number:	3003933619
510(k) Owner:	Mectron S.p.A.Via Loreto, 15/aCarasco - GE 16042, Italy
510(k) Preparer and Contact:	Mr. Edoardo TronchetRegulatory Affairs ManagerMectron S.p.A.Telephone: +39 0185 35361Cell: +39 3371605043

Email: edoardo.tronchet@mectron.com

2. Device identification:

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

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

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 +39 0185 35361 and fax number +39 0185 351374.

medical technology www.mectron.com mectron@mectron.com

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 FLOWPROPHYLAXISMASTER	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.

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.

{6}------------------------------------------------

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 "+39 0185 35361" and fax number "+39 0185 351374".

dical technology mectron@mectron.com

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.

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.

{7}------------------------------------------------

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 +39 0185 35361 and fax number +39 0185 351374.

medical technology www.mectron.com mectron@mectron.com

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.

{8}------------------------------------------------

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 forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
1	Manufacturer	MECTRON SPAVia Loreto 15/A16042 Carasco - Italy	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.31 Ch. de la VuarpilliereNyon Vaud, SWITZERLAND CH-1260	MECTRON SPAVia Loreto 15/A16042 Carasco - Italy	N/A
2	510(k) Number	Subject of this submission	K190124	K140965	N/A
3	Regulationpanel	Dental	Dental	Dental	Identical to PD1 & RD
4	RegulationNumber	21 CFR 872.4850	21 CFR 872.4850	21 CFR 872.4850	Identical to PD1 & RD
5	Common/Usualname andfunction	Ultrasonic scaler/Air Polishing unit	Ultrasonic scaler/Air Polishing unit	Ultrasonic scaler	Identical to PD1Identical to RD for theultrasonic scaler function
6	Product Code	Primary Product code: ELCSubsequent Product Code: KOJ	Primary Product code: ELCSubsequent Product Code: KOJ;	ELC	Identical to PD1Identical to RD for codeELC
7	Classification	Class II	Class II	Class II	Identical to PD1 & RD
8	CombinationProduct	No	No	No	Identical to PD1 & RD
9	Device type	Table top device	Table top device	Table top device	Identical to PD1 & RD
10	Function	Ultrasonic scaling and Air-polishing	Ultrasonic scaling and Air-polishing	Ultrasonic scaling	Identical to PD1 and toRD for the ultrasonicscaler function
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
11	Intended use	combi touch incorporates, within a single device, thefunctions of an ultrasonic scaler and of an air-polishingprophylaxis unit.Ultrasonic scaler function:combi touch, by using the appropriate associated insertsand the ultrasonic handpiece, is intended for use in thefollowing dental applications:• Removing supra and subgingival calculus depositsand stains from teeth• Periodontal therapy and debridement for all typesof periodontal disease, including periodontal pocketlavage with simultaneous ultrasonic tip movement• Scaling and root planing• Releasing crowns, bridges, inlays, and posts aswell as condensing gutta percha• Plugging for amalgam condensation• Amalgam burnishing• Preparing, cleaning and irrigating roots canals• Cavity preparation• Cleaning restorations and implant surfacesAir-polishing prophylaxis function:By using the appropriate air polishing handpiece, combitouch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.The prophylaxis treatment is obtained by the projection ofwater, air and appropriate dental prophylaxis powders, ontothe tooth surface. The device removes dental plaque, softdeposits, and surface stains from pits, grooves,interproximal spaces, or smooth surfaces of teeth.combi touch is intended for the following oral prophylaxisprocedures:• Plaque removal for placement of sealants• Surface preparation prior to bonding/cementation ofinlays, onlays, crowns and veneers• Surface preparation prior to placing compositerestorations• Effective plaque and stain removal for orthodonticpatients• 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 whiteningprocedurescombi touch is also intended for use as an air-polisher inpatients suffering from periodontal disease.	The AIRFLOW Prophylaxis Master combines the functions of anultrasonic scaler and air-polishing unit within a single chassis. TheAIRFLOW Prophylaxis Master is intended for use in the following dentaland periodontal applications:• Removing supra and subgingival calculus deposits and stains fromteeth• Periodontal pocket lavage with simultaneous ultrasonic tip movement• Scaling and root planning• Releasing crowns, bridges, inlays, and posts as well as condensinggutta percha• Plugging for amalgam condensation• Amalgam burnishing• Preparing, cleaning and irrigating roots canals• Cavity preparation• Cementing inlays and onlays• Retrograde preparation of roots canalsThe AIRFLOW Prophylaxis Master is intended for use in the cleaningand polishing of teeth by the projection of water, air, and dental powdersonto the tooth surface. The device removes dental plaque, soft deposits,and surface stains from pits, grooves, interproximal spaces, or smoothsurfaces of teeth.The AIRFLOW Prophylaxis Master can be used for the followingcleaning 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 AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOWProphylaxis Master is indicated for the non-surgical removal ofsubgingival plaque in pockets up to 5 mm after initial periodontaltreatment	The Multipiezo is a piezoelectric ultrasonic dentalscaler intended for use, with the appropriate associatedtip inserts, in the following dental applications:Scaling: All general procedures for removal ofsupragingival/subgingival and interdental calculus/plaque deposits;Periodontology:Periodontal therapy anddebridement for all types of periodontal diseases,including periodontal pocket irrigation and cleaning;Endodontics: All treatments for root canal reaming,irrigation, revision, filling, gutta-percha condensationand retrograde preparation;Restorative and Prosthetics: All general restorativeprocedures including cavity preparation, removal ofprostheses, amalgam condensation, finishing of crownpreparations, inlay/onlay condensation, andimplants/restorations cleaning.	Similar to PD1 except for"cementing inlays andonlays" due to the combitouch cannot perform itand previously clearedapplications of RD
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
		combi touch is indicated for the non-surgical removal ofsubgingival plaque in pockets up to 5 mm after initialperiodontal treatment
12	Anatomical site	Teeth and soft tissues in the mouth	Teeth and soft tissues in the mouth	Teeth and soft tissues in the mouth	Identical to PD1 & RD
13	SpecificTreatment Site	Supragingival and Subgingival	Supragingival and Subgingival	Supragingival	Identical to PD1Subgingival N/A for RD
14	Contactduration	Limited ≤ 24 hours	Limited ≤ 24 hours	Limited ≤ 24 hours	Identical to PD1 & RD
15	Materials indirect contactwith patient:	Stainless steelDiamond coatingTitanium nitride coatingPEEKEVA+LPDEVitonPPSUTPX	Stainless steelTitaniumCOCPPSUEPDMPEEKHytrel SC969	Stainless steelDiamond coatingTitanium nitride coatingPEEK	Similar to PD1 & RD.This difference doesn'timpact on safety orclinical performance
16	Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Similar to PD1 & RD
17	MainComponents ofthe device	• Device core unit.• Irrigation tank complete with cap• Pedal FS-05 with cord and plug• Tank safety cap• Tank cap• Water supply hose with quick coupling• Air supply hose with quick coupling• Water filter• combi touch o-ring kit• Cleaning needle kit• SLIM Scaler Handpiece• Air-polishing handpiece 120°• Air-Polishing handpiece Perio• Water circuit disinfection kit	The Prophylaxis Master consists of:• Unit• Quick guide• Piezon® training tool• Reprocessing instructions• Wireless Foot pedal• US Power cable• AIR-FLOW® PLUS Prophylaxis Powder• AIR-FLOW® CLASSIC Prophylaxis Powder• AIR-FLOW® PLUS Powder chamber• AIR-FLOW® CLASSIC Powder chamber• Piezon® handpiece cord• AIR-FLOW® MAX handpiece cord• Box of AIR-FLOW®• Box of Piezon ®• Piezon® Bottle	• Control unit.• Irrigation liquid bottle• Foot-pedal with cord• Piezoelectric ultrasonic handpiece with led andcord.• Torque wrench to tighten the inserts on thehandpiece.• Power supply cord.• Range of ultrasonic insert tips to be used accordingto the dental applications defined by the intendeduse.• Other accessories/attachments.	Similar There are minimaldifferences in thecomponents related to theUltrasonic scaler functionand Air-polishing function
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
		• Subgingival perio tips• K9 wrench• Ultrasonic Scaling insert S1-S• Ultrasonic Scaling insert P3• Black power supply cable• Use and Maintenance Manual	• Water hose connector• Air hose connector• Clip + clean• Cleaner bottle
18	ProphylaxisPowders usedwith the system	• Sodium Bicarbonate based powder• Glycine based powder	• PERIO (Glycine)• SOFT (Glycine)• CLASSIC (Sodium Bicarbonate)• PLUS (Erythritol)	N/A	The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above:1) was effective in the removal of simulated plaque from dental surfaces.2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment;3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device.
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
19	Prophylaxispowder tanks	Two separated and removable powder tanks, both housedin the casing of the device's console.One tank is dedicated to be used for the supra andsubgingival treatmentsOne tank is dedicated to be used for the subgingivaltreatmentsBoth powder tanks are always available to be usedaccording to the treatment selected from the end user on theconsole's touch panel.	Two removable powder tanksOne tank is dedicated to be used for the supra and subgingivaltreatmentsOne tank is dedicated to be used for the subgingival treatmentsThe tanks can be used one at time only.The end-user must remove from the device's console the tank in use,(containing a type of powder) and insert the tank for the other type ofpowder)	N/A	Identical to PD1
20	TechnologicalCharacteristics- (Mechanism ofaction)	Ultrasonic Scaler Function:Piezoelectric ultrasonic technology thatgeneratesmechanical micro-vibration of the insert tips.The piezoelectric transducer uses piezoceramic disks toconvert the generator's electrical signal to ultrasonicvibration of the insert tip.Air-polishing prophylaxis function:It is based on the principle of projecting a pressurized airmixed with water and a prophylaxis powder on the treatmentsite (tooth surface).	Ultrasonic Scaler Function:Piezoelectric ultrasonic technology that generates mechanical micro-vibration of the insert tips.The piezoelectric transducer uses piezoceramic disks to convert thegenerator'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 withwater and a prophylaxis powder on the tooth surface	Ultrasonic Scaler Function:Piezoelectric ultrasonic technology that generatesmechanical micro-vibration of the insert tips. Thepiezoelectric transducer uses piezoceramic disks toconvert the generator's electrical signal to ultrasonicvibration of the insert tip.	Similar to PD1 and to RDas regards the ultrasonicscaler function.
21	UltrasonicTransducerTechnologicalcharacteristics	Piezoelectric Ultrasonic Technology:The transducer uses piezoceramic disks to convert thegenerator's electrical signal to ultrasonic vibration of thescaler insert tip	Piezoelectric Ultrasonic Technology:The transducer uses piezoceramic disks to convert the generator'selectrical signal to ultrasonic vibration of the scaler insert tip	Piezoelectric Ultrasonic Technology:The transducer uses piezoceramic disks to convertthe generator's electrical signal to ultrasonic vibrationof the scaler insert tip	Identical to PD1 & RD
22	Led systemincorporatedinside theultrasonic scalerhandpiece toprovide illumina-tion of theoperative site.	YES	YES	YES	Similar to PD1.Identical to RD
23	Handpieces	The subject device can be used with five separatehandpieces:	The predicate device can be used has three separated handpieces.- One ultrasonic piezoelectric handpiece intended for the scalingtreatments.	The device operates with one piezoelectric ultrasonichandpiece.	Similar to PD1 for scalingand prophylaxis treatmentIdentical to RD for theultrasonic scaler function
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
		- Two ultrasonic piezoelectric handpiece intended forthe scaling treatments (SLIM scaler handpiece and LEDscaler handpiece)- One air-polishing handpiece 120° dedicated to performsupra-gingival prophylaxis treatment.- One air-polishing handpiece 90° dedicated to performsupra-gingival prophylaxis treatment.- One air-polishing handpiece PERIO dedicated toperform sub-gingival use in periodontal treatments - usein conjunction with the subgingival perio tips	- One air-polisher handpiece dedicated to perform supra-gingivalprophylaxis treatment.- One air-polisher handpiece dedicated to perform sub-gingivalprophylaxis treatment.
24	Subgingivalperiodontal tip	YES	YES	N/A	Similar to PD1
25	Max powerConsumption	90 VA	700 VA	90 VA	This difference doesn'timpact on safety orclinical performance.Identical to RD
26	UltrasoundFrequency	24 kHz to~36 kHz	24 kHz to~32 kHz	24 kHz to~36 kHz	Similar to PD1 andidentical to RD
27	Flow rateadjustment	Mechanical regulator + Touch panel	Mechanical regulator	Touch panel	Similar to PD1 andidentical to RD
28	Foot pedal	Wired	Wireless or wired	Wired	Similar to PD1 andidentical to RD
29	Electrical powerinput	100 - 240 VAC - 50/60 Hz.	100 - 240 VAC - 50/60 Hz.	100 - 240 VAC - 50/60 Hz.	Identical to PD1 & RD
30	Water deliverysystem	One irrigating liquid bottle for ultrasonic scaling treatmentConnection to external water supply for both ultrasonicscaling and air-polishing treatment	One irrigating liquid bottle for ultrasonic scaling treatmentConnection to external water supply for both ultrasonic scaling andair-polishing treatment	One irrigating liquid bottle for ultrasonic scalingtreatment	Identical to PD1 and RDfor the scaling treatment
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item forcomparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
31	Electrical safety	Complies with IEC 60601-1	Complies with IEC 60601-1	Complies with IEC 60601-1	Identical to PD1 & RD
32	ElectromagneticCompatibility	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2	Identical to PD1 & RD
33	Device containssoftware?	YES	YES	YES	Identical to PD1 & RD
34	Parts suppliedsterile	YES (Subgingival Perio Tips).The shelf life is 5 years	NO	N/A	The Subgingival Perio Tipmaterial composition wasfound to be incompatiblewith reprocessingby steam sterilization dueto a melting point lowerthan the requiredsterilization temperature(132°C). Also for theUS market, it was decidedto make the SubgingivalPerio Tip available insterile condition andfor single use only.
35	Parts need tobe sterilizedprior use?	YESSLIM scaler handpiece and LED scaler handpiece air-polishing handpiece 120° air-polishing handpiece 90° air-polishing handpiece PERIO Ultrasonic Scaling Inserts Torque wrenches Irrigation kit	YES AIR-FLOW® handpiece PERIOFLOW® handpiece Piezon ® handpiece Scaler Insert Torque wrench CLIP + CLEAN	YES SLIM scaler handpiece and LED scaler handpiece Ultrasonic Scaling Insets Torque wrenches	Similar to PD1 and RD
36	Shelf life	Unrestricted	Unrestricted	Unrestricted	Identical
37	Recommendedsterilizationmethod	Autoclaving (Steam Sterilization)	Autoclaving (Steam Sterilization)	Autoclaving (Steam Sterilization)	Identical to PD1 & RD
Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item for comparison	COMBI TOUCHSubject Device	EMS AIRFLOW PROPHYLAXIS MASTERPrimary Predicate Device - PD1 - K190124	MULTIPIEZOReference Device - RD - K140965	Variations
38	Flush function:washing of the liquid circuit	YES	YES	YES	Similar to PD1 and identical to RD
39	Compressed air supply	4 to 8 Bar	4.5 to 7 Bar	N/A	Similar-Difference with no impact on the safety and effectiveness of the subject device
40	Water supply	1 to 6 Bar	2 to 5 Bar	N/A	Similar-Difference with no impact on the safety and effectiveness of the subject device
41	Dimensions:(HxWxD)Weight (approx)	145 x 260 x 4104,8 KgImage: COMBI TOUCH	245 x 260 x 2905 Kg max.Image: EMS AIRFLOW PROPHYLAXIS MASTER	145 x 230 x 3202,4 KgImage: MULTIPIEZO	Similar to PD1 and RD since all the devices have dimensions and weights consistent with the table top use

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the word "mectron" in orange font. Below the word, there are several gray circles. The circles are arranged in a horizontal line.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "mectron" in orange font. The letters are connected to a series of gray dots that are in a horizontal line. The word is partially obscured by a gray rectangle on the left side of the image.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image contains the word "mectron" in orange font. Below the word are five gray circles. The circles are evenly spaced and appear to be part of the logo.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the word "mectron" in orange font. Below the word, there are several gray dots. The dots are arranged in a row and appear to be part of the logo.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image contains the word "mectron" in orange font. Below the word are several gray circles. The circles are arranged in a row.

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the word "mectron" in orange font. Below the word, there is a row of gray dots. The dots are evenly spaced and appear to be part of the logo.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for Mectron. The word "mectron" is written in orange, with the "m" in gray. Below the word "mectron" is a series of gray circles that are connected by a gray line.

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the word "mectron" in orange font. Below the word "mectron" are four gray circles. The circles are aligned horizontally and are evenly spaced.

Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374

medical technology

www.mectron.com mectron@mectron.com

Substantial Equivalence Discussion

The proposed device and the predicate device AIRFLOW Prophylaxis Master (K190124 cleared on 20/10/2019) have the intended use substantially identical

The proposed device and the predicate device share also many identical features, including identical/equivalent principle of operation and technological characteristics

The differences identified in the above table 1.1 clearly have no impact on safety or effectiveness of the device. Any differences identified in above table does not introduce any new questions regarding safety and effectiveness.

These considerations are also confirmed by the performance test carried out in comparison with the predicate device PD1.

The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States.

7. Summary of Non-Clinical Testing - List of Standards

Testing was performed to verify compliance of the combi touch with the list standards listed here below:

Standard	Title	FDARecognitionNumber
CEI UNI EN ISO 14971:2019	Medical devices - Application of risk management to medical devices	5-125
ISO/TR 24971:2020	Medical devices — Guidance on the application of ISO14971	-
IEC 60601-1:2015, AMD1:2012	Medical electrical equipment — Part 1 — General Requirements for Safety	19-46
IEC 60601-1-2:2014; IEC 60601-1-2:2014/AMD1:2020	Medical Electrical equipment - PART 1-2: General Requirements for basicsafety and essential performance - Collateral Standard: ElectromagneticDisturbances — Requirements and tests	19-36
IEC 60601-1-6:2010 AMD1:2013	General requirements for basic safety and essential performance -Collateral standard: Usability	5-89
IEC 62366: 2007/AMD1:2014	Medical devices - Application of usability engineering to medical devices	-
IEC 62304:2006 +IEC 62304:2006/AMD1:2015	Medical device software - Software life-cycle processes	13-79
ASTM D4169-16	Standard Practice for Performance Testing of Shipping Containers andSystems	14-499
ISO 7153-1:2016	Surgical Instruments - Materials - Part 1: Metals	8-344
ASTM F899-20	Standard Specification for Wrought Stainless Steel for Surgical Instruments	8-527
ASTM F136-13	Standard Specification for Wrought Titanium-6Aluminum- 2013 4 VanadiumELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401)	8-377
EN 10088-3:2014	Stainless steels - Part 3: Technical delivery conditions for semi-finishedproducts, bars, rods, wire, sections and bright products of corrosionresisting steels for general purposes	-
EN ISO 11737-1:2018/AMD 1:2021	Determination of a population of microorganisms on products	14-577
EN ISO 11737-2:2020	Tests of sterility performed in the definition, validation and maintenance of asterilization process	14-540
Standard	Title	FDARecognitionNumber
EN 62353:2015	Medical electrical equipment - Recurrent test and test after repair ofmedical electrical equipment	-
IEC 62471:2006EN 62471:2008	Photo biological safety of lamps and lamp systems	12-249
IEC 80601-2-60:2019	Medical electrical equipment - Part 2-60: Particular requirements for thebasic safety and essential performance of dental equipment	4-262
ISO 10993-1:2018	Biological evaluation of medical devices - Evaluation and testing within arisk management process	2-258
UNI EN ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity	2-245
UNI EN ISO 10993-7:2008	Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals [Including: Technical Corrigendum 1 (2009),AMENDMENT 1: Applicability of allowable limits for neonates and infants(2019)]	2-275
ISO 10993-10:2021	Biological evaluation of medical devices - Part 10: Tests skin sensitization	2-296
ISO 10933-11:2017	Biological evaluation of medical devices - Part 11: Tests for systemictoxicity	2-255
ISO 10993-12:2021	Biological evaluation of medical devices Sample preparation and referencematerials	2-289
ISO 11607-1:2019	Packaging for terminally sterilized medical devices - Part 1: Requirementsfor materials, sterile barrier systems and packaging systems	14-530
ISO 11607-2:2019	Packaging for terminally sterilized medical devices - Part 2: Validationrequirements for forming, sealing and assembly processes	14-530
UNI EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirementsand test methods	-
EN ISO 15223-1:2021	Medical devices - Symbols to be used with information to be supplied bythe manufacturer - Part 1: General requirements	5-134
UNI 556-1:2002/AC:2006	Sterilization of Medical devices - Requirements for medical devices to bedesignated "STERILE" – Part 1 – Requirements for terminally sterilizedmedical devices.	-
AAMI ST77:2013/®:2018	Containment devices for reusable medical device sterilization.	14-396
AAMI ST79:2017	Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.	14-562
AAMI ST8:2013	Hospital Steam Sterilizers	14-406
ISO 15883-1:2007	Washer-disinfectors - Part 1: General requirements, terms and definitionsand tests	-
ISO/TS 15883-5:2005	Washer-disinfectors - Part 5: Test soils and methods for demonstratingcleaning efficacy 2005.	-
ISO 15883-5:2021	Washer-disinfectors - Part 5: Performance requirements and test methodcriteria for demonstrating cleaning efficacy	-
AAMI TIR12:2010	Designing, testing, and labeling reusable medical devices for reprocessingin health care facilities: A guide for medical device manufacturers	-
AAMI TIR28:2016	Product adoption and process equivalence for ethylene oxide sterilization	-
AAMI TIR30:2011 (R2016)	A compendium of processes, materials, test methods, and acceptancecriteria for cleaning reusable medical devices	-
ISO 17664-1:2021	Processing of health care products - Information to be provided by themedical device manufacturer for the processing of medical devices - Part1: Critical and semi-critical medical devices	14-578
EN ISO 15883-4:2018	Washer-disinfectors - Part 4: Requirements and tests for washerdisinfectors employing chemical disinfection for thermolabile endoscopes	-
ASTM E1837- 96 (Reapproved2014)	Standard Test Method to Determine Efficacy of Disinfection Processes forReusable Medical Devices (Simulated Use Test)	-
AFNOR NF T 72-281, 2014	Methods of airborne disinfection of surfaces Determination of bactericidal,yeasticidal, mycobactericidal, tuberculicidal, sporicidal and virucidal activity,including bacteriophages.	-
EN 1276:2019	Chemical disinfectants and antiseptics - Quantitative suspension test forthe evaluation of bactericidal activity of chemical disinfectants and	-
Standard	Title	FDARecognitionNumber
	antiseptics used in food, industrial, domestic and institutional areas – Testmethod and requirements (phase 2, step 1).
EN ISO 11135:2014/A1:2019	Sterilization of health-care products – Ethylene oxide – Requirements forthe development, validation and routine control of a sterilization process formedical devices	14-529
ISO 11138-1:2017	Sterilization of health care products – Biological indicators – Part 1:General requirements	14-502
ISO 11138-2:2017	Sterilization of health care products – Biological indicators – Part 2:Biological indicators for ethylene oxide sterilization processes	-
ISO 11138-3:2017	Sterilization of health care products – Biological indicators – Part 3:Biological indicators for moist heat sterilization processes	-
ISO 11138-7:2017	Sterilization of health care products – Biological indicators – Part 7:Guidance for the selection, use and interpretation of results	-
EN ISO 11737-1:2015	Sterilization of health care products – Microbiological methods – Part 1:Determination of a population of microorganism on products	-
EN ISO 11737-2:2020	Sterilization of health care products – Microbiological methods – Part 2:Test of sterility performed in the definition, validation and maintenance of asterilization process	-
UNI EN 868-2:2009	Packaging for terminally sterilized medical devices – Part 2: Sterilizationwrap - Requirements and test methods	-
ISO 17665-1:2006	Sterilization of health care products – Moist heat – Requirements fordevelopment, validation and routine control of a sterilization process formedical devices.	14-333
AAMI/ISO TIR 17665-2:2009	Sterilization of health care products – Moist heat – Part 2: Guidance onthe application of ISO 17665-1.	14-277
EN ISO 5349-1:2001	Mechanical vibration – Measurement and evaluation of human exposure tohand-transmitted vibration – Part 1: General requirements	-
ISTA 2A :2011	Packaged-Products 150 lb (68 kg) or less	-
UNI EN ISO 5349-2:2015	Mechanical vibration – Measurement and evaluation of human exposureto hand-transmitted vibration – Part 2: Practical guidance for measurementat the workplace	-
EN ISO 20417:2021	Medical devices - Information to be supplied by the manufacturer	5-135

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the word "mectron" in orange font. Below the word, there are several gray circles. The circles are arranged in a row.

Mectron S.p.A.
Via Loreto, 15/A
16042 Carasto, 15/A
16042 Carasto – GE (Italy)
Tel. +39 0185 35361
Fax +39 0185 351374

medical technology

www.mectron.com
mectron@mectron.com

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the word "mectron" in orange font. Below the word "mectron" are six gray circles. The circles are arranged in two rows of three.

Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374

medical technology

www.mectron.com mectron@mectron.com

The results of the tests have demonstrated the safety and effectiveness of the Combi Touch device for the indication for use reported in section 5.

Summary of Clinical Testing 8.

Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices

CONCLUSION 9.

Based on the comparative analysis and testing contained within this submission, it is concluded that the combi touch device has intended use, safety and effectiveness profile, and technological characteristics, substantially equivalent to the identified predicate / reference devices which are already in commercial distribution in the United States.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
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.(b)
Classification. Class II.