EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

K190124 · E.M.S Electro Medical Systems S.A · ELC · Oct 20, 2019 · Dental

Device Facts

• Record ID: K190124
• Device Name: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: ELC · Dental
• Decision Date: Oct 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications: - Removing supra and subgingival calculus deposits and stains from teeth - 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 root canals - Cavity preparation - Cementing inlays and onlays - Retrograde preparation of root canals The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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. The AIRFLOW Prophylaxis Master can be used for the following cleaning 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 AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Device Story

The EMS AIRFLOW Prophylaxis Master and AIRFLOW One are dental devices used for cleaning, polishing, and periodontal therapy. The Prophylaxis Master integrates an ultrasonic scaler and air-polishing unit; the AIRFLOW One provides air-polishing only. Both devices project a mixture of water, air, and dental powders (sodium bicarbonate, glycine, or erythritol) onto tooth surfaces to remove plaque, soft deposits, and stains. The Prophylaxis Master uses an ultrasonic handpiece for scaling and root planing. Operated by dental professionals in clinical settings, the devices feature a control unit, handpieces, and a foot pedal (wired or wireless). The output allows clinicians to perform procedures like periodontal pocket lavage, cavity preparation, and surface preparation for bonding. By removing calculus and plaque, the device supports periodontal health and prepares teeth for restorative or orthodontic treatments.

Clinical Evidence

No clinical testing was conducted for this submission. Substantial equivalence is based on non-clinical performance testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: Titanium, COC, PPSU, EPDM, Stainless Steel, PEEK, Hytrel SC969. Energy: 100-240 VAC, 50-60Hz. Ultrasonic scaling (Prophylaxis Master only): 24-32 kHz, 8W max output. Connectivity: Wired/wireless foot pedal. Software: Embedded firmware (ES-087, ES-091, ES-125, ES-046). Sterilization: Non-sterile, resterilizable components. Form factor: Control unit with powder chambers and irrigation liquid containers.

Indications for Use

Indicated for dental cleaning and periodontal therapy in patients requiring removal of supra/subgingival calculus, plaque, and stains. Includes scaling, root planing, endodontic irrigation, and surface preparation for restorations/orthodontics. Indicated for 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

• AIR-FLOW MASTER PIEZON (K110173)

Submission Summary (Full Text)

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October 20, 2019

E.M.S Electro Medical Systems S.A. % Christina Henza Regulatory Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave Libertyville, Illinois 60048

Re: K190124

Trade/Device Name: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC, KOJ Dated: September 19, 2019 Received: September 20, 2019

Dear Christina Henza:

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 medical devices and radiation-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.

Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K190124

Device Name EMS AIRFLOW Prophylaxis Master

#### Indications for Use (Describe)

The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications:

- · Removing supra and subgingival calculus deposits and stains from teeth
- · 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 root canals
- · Cavity preparation
- · Cementing inlays and onlays
- · Retrograde preparation of root canals

The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW Prophylaxis Master can be used for the following cleaning 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 AIRFLOW Prophylaxis Master 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)

FORM FDA 3881 (7/17)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

EF

PSC Publishing Services [phone]

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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]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K190124

Device Name EMS AIRFLOW One

The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW One can be used for the following cleaning procedures:

- · plaque removal for placement of sealants
- · surface preparation prior to bonding/cementation of inlays, 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 One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One 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."

FORM FDA 3881 (7/17)

EF

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### SECTION 5: 510(k) Summary

#### Traditional 510(k) Premarket Notification

## E.M.S. Electro Medical Systems S.A. EMS AIRFLOW Prophylaxis Master and EMS AIRFLOW One

#### 510(k) Summary

#### 1. Submitter/510(k) Holder

E.M.S. Electro Medical Systems S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

| Primary Contact Person: | Gaëlle Pacaud |
|-------------------------|------------------------------------------------------------|
| | Regulatory Affairs Coordinator |
| Telephone: | [phone] |
| E-mail: | <a href="mailto:[e-mail]">[e-mail]</a> |
| Submission Contact: | Christina Henza |

[e-mail]

Date Prepared: January 14, 2019

#### 2. Device Name

Proprietary Name: EMS AIRFLOW Prophylaxis Master Common/Usual Name: Ultrasonic Scaler/Air Polishing Unit Classification Name: Ultrasonic Scaler (21 CFR 872.4850) Device Class: Product Code: ELC*

*The EMS AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and airpolishing unit. The predicate AIR-FLOW MASTER PIEZON, which was cleared with dual ultrasonic scaling and air-polishing functions, was classified by FDA as an ultrasonic scaler.

Proprietary Name: EMS AIRFLOW One Common/Usual Name: Air Polishing Unit Airbrush (21 CFR 872.6080) Classification Name: Device Class: ll Product Code: KOJ

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# 3. Predicate Devices

The proposed EMS AIRFLOW Prophylaxis Master and AIRFLOW One are substantially equivalent to the legally marketed AIR-FLOW MASTER PIEZON (K110173, cleared on 04/07/2011). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

# 4. Device Description

The EMS AIRFLOW Prophylaxis Master is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device.

The AIRFLOW Prophylaxis Master is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.

The AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders.

The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces.

The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.

# 5. Indications for Use

The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications:

- Removing supra and subgingival calculus deposits and stains from teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement ●
- Scaling and root planing .
- Releasing crowns, bridges, inlays, and posts as well as condensing gutta . percha

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- Plugging for amalgam condensation .
- Amalgam burnishing .
- . Preparing, cleaning and irrigating root canals
- Cavity preparation .
- Cementing inlays and onlays .
- . Retrograde preparation of root canals

The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW Prophylaxis Master can be used for the following cleaning 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 intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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.

The AIRFLOW One can be used for the following cleaning 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 One is intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of

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subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

# 6. Summary of Technological Characteristics Compared to the Predicate Devices

The proposed devices and the predicate have similar technological characteristics. The overall design and functions of the proposed AIRFLOW Prophylaxis Master and AIRFLOW One are identical to those of the predicate AIR-FLOW MASTER PIEZON. The modifications made to the AIR-FLOW MASTER PIEZON to produce the AIR-FLOW Prophylaxis Master and the AIRFLOW One are limited to some improvements in terms of aesthetics and ergonomics.

The safety and effectiveness questions regarding the modifications to the AIR-FLOW MASTER PIEZON to produce the AIRFLOW Prophylaxis Master and the AIRFLOW One are whether the devices maintain their reliability and electrical safety characteristics and whether the use is adequately described within the instructions for use. These questions apply to both the proposed devices and the predicate. The proposed devices do not raise different questions of safety and effectiveness than the predicate.

Therefore, the proposed devices, AIRFLOW Prophylaxis Master and AIRFLOW One, meet substantial equivalence requirements with regards to the legally marketed predicate AIR-FLOW MASTER PIEZON (K110173 cleared on 04/07/2011).

A side-by-side comparison of the predicate device and the proposed devices is provided in Table 5-1 in the following page.

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| Substantial Equivalence Table | | | | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Item for Comparison | Proposed Device<br>(AIRFLOW Prophylaxis Master) | Proposed Device<br>(AIRFLOW One) | Predicate Device<br>(AIR-FLOW MASTER PIEZON) | Variations |
| REGULATORY INFORMATION | Name | AIRFLOW Prophylaxis Master | AIRFLOW One | AIR-FLOW MASTER PIEZON | N/A |
| | 510(k) Number | Pending | Pending | K110173 | N/A |
| | Predicates | K110173 | K110173 | K093000, K092289, K082791, K073284,<br>K900709, K093723 | N/A |
| | Product Code | ELC | KOJ | ELC | Same for AIRFLOW Prophylaxis Master.<br>Equivalent for AIRFLOW One. |
| | Subsequent<br>Product Codes | KOJ<br>EJR | EJR | EFB (now KOJ)<br>EJR | Same |
| | Class | II | II | II | Same |
| | Combination<br>Product | No | No | No | Same |
| | Regulation<br>Number | 872.4850 | 872.6080 | 872.4850 | Same for AIRFLOW Prophylaxis Master.<br>Equivalent for AIRFLOW One. |
| | Regulation<br>Generic Name | Ultrasonic scaler | Airbrush | Ultrasonic scaler | Equivalent for AIRFLOW One. |
| INTENDED USE | Regulation<br>Intended Use | "for use during dental cleaning and<br>periodontal (gum) therapy to remove calculus<br>deposits from teeth by application of an<br>ultrasonic vibrating scaler tip to the teeth" | "for use in conjunction with articulation paper.<br>The device uses air-driven particles to<br>roughen the surfaces of dental restorations.<br>Uneven areas of the restorations are then<br>identified by use of articulation paper" | "for use during dental cleaning and<br>periodontal (gum) therapy to remove calculus<br>deposits from teeth by application of an<br>ultrasonic vibrating scaler tip to the teeth" | Same for AIRFLOW Prophylaxis Master.<br>Equivalent for AIRFLOW One. |
| | Indications for<br>use | The AIRFLOW Prophylaxis Master combines<br>the functions of an ultrasonic scaler and air-<br>polishing unit within a single chassis. The<br>AIRFLOW Prophylaxis Master is intended for<br>use in the following dental and periodontal<br>applications:<br>• Removing supra and subgingival calculus<br>deposits and stains from teeth<br>• Periodontal pocket lavage with |…