AIR-FLOW PLUS Prophylaxis powder

K171189 · E.M.S Electro Medical Systems S.A · EJR · Sep 11, 2017 · Dental

Device Facts

• Record ID: K171189
• Device Name: AIR-FLOW PLUS Prophylaxis powder
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: EJR · Dental
• Decision Date: Sep 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6030
• Device Class: Class 1

Intended Use

The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

Device Story

AIR-FLOW PLUS Prophylaxis Powder consists of erythritol with 0.05% Cetyl Pyridinium Chloride (CPC) preservative. Used with EMS dental handpieces for supra- and subgingival cleaning and tooth preparation. Principle of operation involves mixing powder with air and water in handpiece nozzle to create mechanically abrasive stream. Operated by dental professionals in clinical settings. CPC additive prevents bacterial contamination from humidity/microorganisms. Output is abrasive spray for dental prophylaxis. Benefits include efficient cleaning and preparation of tooth surfaces. No clinical studies conducted; performance verified via bench testing.

Clinical Evidence

Bench testing only. Comparison testing against predicate (PERIO) and reference (SOFT) powders evaluated cleaning efficiency and abrasivity. Cleaning efficiency measured via paint removal from metal plates; abrasivity measured via erosion of PEEK material. Results demonstrated PLUS powder is equivalent in abrasivity and more efficient in cleaning compared to predicates. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1.

Technological Characteristics

Material: Erythritol with 0.05% Cetyl Pyridinium Chloride (CPC). Principle: Mechanical abrasion via air/water/powder mixture. Form factor: Prophylaxis powder. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for cleaning and preparation of teeth using EMS dental handpieces. No specific patient population age or gender restrictions provided.

Regulatory Classification

Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Predicate Devices

• E.M.S PERIO Powder (K082791)

Reference Devices

• E.M.S. Soft Powder (K110173)
• CLASSIC powder
• COMFORT powder

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2017

E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy Regulatory Affairs Manager -- Dental Chemin de la Vuarpilliere 31 CH-1260 Nyon SWITZERLAND

Re: K171189

Trade/Device Name: AIR-FLOW PLUS Prophylaxis powder Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: Class I Product Code: EJR Dated: June 20, 2017 Received: June 20, 2017

Dear Suzanne Fassio-Hardy:

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. 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171189

Device Name

AIR-FLOW PLUS Prophylaxis Powder

### Indications for Use (Describe)

The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

| Type of Use (Select one or both, as applicable) | |
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× | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510 (k) Summary for AIR-FLOW PLUS Prophylaxis Powder (K171189)

# Date: May 10, 2017

#### l. SUBMITTTER/ 510(K) HOLDER

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

Primary Contact:

Suzanne FASSIO-HARDY, Regulatory Affairs Manager – Dental Direct: [phone] Email: [e-mail]

Submission Contact:

Christina Henza [e-mail]

- II. DEVICE NAME
Proprietary Name: AIR-FLOW PLUS Prophylaxis Powder Common/Usual Name: Prophylaxis Powder

Classification Name: Oral cavity abrasive polishing agent (872.6030) Device Class: I Product Code: EJR

#### III. PREDICATE DEVICES

The AIR-FLOW PLUS Prophylaxis Powder is a substantially equivalent new version of the legally marketed 510(k) exempt powders E.M.S PERIO Powder (predicate, exempt but included in K082791 cleared on 02/18/2009) and E.M.S. Soft Powder(reference device exempt but included in K110173 cleared on 04/07/2011). The proposed device is submitted via premarket notification [510(k) pathway] because the addition of CPC will exceed the limitations of the exemptions listed in Sec. 872.9 (b); since CPC has preservative properties, it is considered to be a different fundamental technology.

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Neither the predicate device nor reference device have not been subject to a designrelated recall.

#### IV. DEVICE DESCRIPTION

The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes.

The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.

- V. INDICATIONS FOR USE
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE

The proposed AIR-FLOW PLUS Prophylaxis Powder is intended to be used with all currently available EMS AIR-FLOW and PERIO-FLOW dental handpieces.

At a high level, the subject and predicate devices are based on the following same technological elements:

- Used in EMS AIR-FLOW devices
- Powder is mixed with water and air

The following technological differences exist between the subject and predicate devices:

- The proposed powder material is erythritol with CPC, the predicate powders are Glycine
- . Reduced grain size of powder

The safety and effectiveness questions regarding the material differences are biocompatiblity and performance within the dental handpiece devices. These questions apply to both the new device and the predicate and so the new device does not raise different questions of safety and efficacy. Therefore, the proposed device, AIR-FLOW PLUS Prophylaxis Powder, meets substantial equivalence requirements with regards to the legally marketed 510(k) exempt powders PERIO Prophylaxis Powder.

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#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Shelflife testing:

- 24 months real time aging
### Biocompatibility testing:

The biocompatibility evaluation for the AIR-FLOW PLUS Prophylaxis Powder was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "Surface device -breached or compromised surface" per section 5.2.1(c). The device will have limited contact of less than or equal to 24 hours. Testing completed on this device includes:

- Cytotoxicity
- Sensitization
- Irritation

## Comparison Testing:

To verify that the change of material (ingredients and size) does not impact the performance of the powder, functional testing was completed on the proposed device and the predicate devices. Since the requirements for a subgingival powder differ from the requirements of a supra gingival powder, comparison testing is separated into two reports as described below.

Subgingival Applications [comparison to predicate powder (PERIO)]

Comparison testing between the PERIO (predicate) and PLUS (proposed) powders included a cleaning test and an abrasivity test.

The performance of the powder is measured by the capability to clean a metallic plate and by the abrasivity of the powder itself. The cleaning test compares the ability of the powders' to remove paint from a metal plate and the abrasivity test compares the powders' erosion of a known material (PEEK). The results of these two comparison tests show that the two powders are equivalent with respect to performance (abrasivity test) however the PLUS powder (proposed) is more efficient with respect to cleaning.

Supragingival Applications [comparison to reference device powder (SOFT) ]

Comparison testing consists of cleaning efficiency test between the SOFT (reference device) and PLUS (proposed) powders, as well as several other marketed supra gingival powders (CLASSIC, COMFORT, and SOFT). The test is performed using an automated test bench to clean a painted metal surface. Cleaning efficiency is a calculation of flow-rate and time to clean. The results of this comparison test show that the PLUS (proposed) powder is more efficient than the SOFT (reference device), however the cleaning efficiency is similar to other marketed powders.

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All tests were successfully performed and all acceptance criteria were met, thus confirming that AIR-FLOW PLUS Prophylaxis Powder satisfactorily meet requirements. No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of comparison testing.

#### CONCLUSIONS VIII.

Based on the information and supporting documentation provided in the premarket notification, the AIR-FLOW PLUS Prophylaxis Powder is substantially equivalent to the cited predicate and reference devices. Testing demonstrates that the AIR-FLOW PLUS Prophylaxis Powder fulfills prospectively defined design and performance specifications.