(268 days)
Not Found
No
The summary describes a dental device combining ultrasonic scaling and air-polishing functions. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, decision-making, or automated control beyond standard device operation. The performance studies focus on compliance with safety and effectiveness standards for medical devices, not on the performance of an AI/ML algorithm.
Yes
The device is described as an ultrasonic scaler and air-polishing unit for various dental applications, including removing calculus, plaque, and stains, as well as being indicated for non-surgical removal of subgingival plaque in periodontal disease. These actions directly address and treat dental and periodontal conditions, classifying it as a therapeutic device.
No
The device is intended for cleaning, polishing, and removing deposits from teeth. Its functions are therapeutic/prophylactic procedures, not diagnostic ones.
No
The device description clearly outlines physical hardware components including a control unit, hoses, handpieces, a foot pedal, and powder chambers. It is a physical medical device with integrated software for control, not a software-only device.
Based on the provided text, the AIRFLOW Prophylaxis Master and AIRFLOW One are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended uses described for the AIRFLOW devices are all related to direct treatment and cleaning of teeth and surrounding tissues within the mouth. They involve physical actions like removing deposits, scaling, polishing, and preparing surfaces.
- Device Description: The device description details a system that delivers water, air, and powder directly to the tooth surface and uses ultrasonic vibrations. This is consistent with a dental treatment device, not a device that analyzes biological specimens.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
The devices are clearly intended for dental procedures performed directly on the patient's teeth and gums, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ELC, KOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth and soft tissues in the mouth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing was performed to verify compliance of the AIRFLOW Prophylaxis Master and AIRFLOW One with several standards, including ISO 14971, ISO 17664, ISO 17665-1, ANSI/AAMI ST79, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, IEC 62304, ISO 15223-1, ISO 10993-1, ISO 7405, and ISTA 2A. The results confirm that the devices are safe and effective for the described indications for use. No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 (301) 443-6740
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
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 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."
FORM FDA 3881 (7/17)
EF
5
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: | +41229948522 |
| E-mail: | gpacaud@ems-ch.com |
| Submission Contact: | Christina Henza |
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
6
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
7
- 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
8
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.
9
| Substantial Equivalence Table | |||||
|---|---|---|---|---|---|
| Item for Comparison | Proposed Device | ||||
| (AIRFLOW Prophylaxis Master) | Proposed Device | ||||
| (AIRFLOW One) | Predicate Device | ||||
| (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, | ||
| K900709, K093723 | N/A | ||||
| Product Code | ELC | KOJ | ELC | Same for AIRFLOW Prophylaxis Master. | |
| Equivalent for AIRFLOW One. | |||||
| Subsequent | |||||
| Product Codes | KOJ | ||||
| EJR | EJR | EFB (now KOJ) | |||
| EJR | Same | ||||
| Class | II | II | II | Same | |
| Combination | |||||
| Product | No | No | No | Same | |
| Regulation | |||||
| Number | 872.4850 | 872.6080 | 872.4850 | Same for AIRFLOW Prophylaxis Master. | |
| Equivalent for AIRFLOW One. | |||||
| Regulation | |||||
| Generic Name | Ultrasonic scaler | Airbrush | Ultrasonic scaler | Equivalent for AIRFLOW One. | |
| INTENDED USE | Regulation | ||||
| Intended Use | "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" | "for use in conjunction with articulation paper. | ||||
| The device uses air-driven particles to | |||||
| roughen the surfaces of dental restorations. | |||||
| Uneven areas of the restorations are then | |||||
| identified by use of articulation paper" | "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" | Same for AIRFLOW Prophylaxis Master. | ||||
| Equivalent for AIRFLOW One. | |||||
| 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 | The AIR-FLOW MASTER PIEZON combines | ||||
| the functions of an ultrasonic scaler and air- | |||||
| polishing unit within a single chassis. The | |||||
| AIR-FLOW MASTER PIEZON 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 | Same | ||||
| Substantial Equivalence Table | |||||
| Item for Comparison | Proposed Device | ||||
| (AIRFLOW Prophylaxis Master) | Proposed Device | ||||
| (AIRFLOW One) | Predicate Device | ||||
| (AIR-FLOW MASTER PIEZON) | Variations | ||||
| 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 | N/A | ||||
| 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 also intended for use | |||||
| as an air-polisher in patients suffering from | |||||
| periodontal disease. The AIRFLOW One is | 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON is also | |||||
| intended for use as an air-polisher in patients | |||||
| suffering from periodontal disease. The AIR- | |||||
| Substantial Equivalence Table | |||||
| Item for Comparison | Proposed Device | ||||
| (AIRFLOW Prophylaxis Master) | Proposed Device | ||||
| (AIRFLOW One) | Predicate Device | ||||
| (AIR-FLOW MASTER PIEZON) | Variations | ||||
| TECHNOLOGICAL CHARACTERISTICS | AIRFLOW Prophylaxis Master is indicated for | ||||
| the non-surgical removal of subgingival | |||||
| plaque in pockets up to 5 mm after initial | |||||
| periodontal treatment. | indicated for the non-surgical removal of | ||||
| subgingival plaque in pockets up to 5 mm | |||||
| after initial periodontal treatment. | FLOW MASTER PIEZON is indicated for the | ||||
| non-surgical removal of subgingival plaque in | |||||
| pockets up to 5 mm after initial periodontal | |||||
| treatment. | |||||
| Anatomical sites | Teeth and soft tissues in the mouth. | Teeth and soft tissues in the mouth | Teeth and soft tissues in the mouth. | Same | |
| Specific | |||||
| Treatment site | Supragingival and Subgingival | Supragingival and Subgingival | Supragingival and Subgingival | Same | |
| Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Limited ≤ 24 hours | Same | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Same | |
| Patient | |||||
| Contacting | |||||
| Materials | Titanium | ||||
| COC | |||||
| PPSU | |||||
| EPDM | |||||
| Stainless Steel | |||||
| PEEK | |||||
| Hytrel SC969 | Stainless Steel | ||||
| PEEK | |||||
| Hytrel SC969 | Titanium | ||||
| COC | |||||
| PPSU | |||||
| EPDM | |||||
| Stainless Steel | |||||
| PEEK | |||||
| Hytrel SC969 | Same | ||||
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Same | |
| Shelf life | Unrestricted | Unrestricted | Unrestricted | Same | |
| General purpose | Dental cleaning and periodontal (gum) | ||||
| therapy | Dental cleaning and periodontal (gum) | ||||
| therapy | Dental cleaning and periodontal (gum) | ||||
| therapy | Same | ||||
| Functions | Ultrasonic scaling and air-polishing | Air-polishing | Ultrasonic scaling and air-polishing | Same | |
| Mechanism of | |||||
| action | • Application of an ultrasonic vibrating scaler | ||||
| tip to the teeth | |||||
| • Projection of water/air/powder mixture | • Projection of water/air/powder mixture | • Application of an ultrasonic vibrating scaler | |||
| tip to the teeth | |||||
| • Projection of water/air/powder mixture | Same | ||||
| Electric power | |||||
| supply | • 100-240 VAC | ||||
| • 50-60Hz | • 100-240 VAC | ||||
| • 50-60Hz | • 100-240 VAC | ||||
| • 50-60Hz | Same | ||||
| Ultrasonic | |||||
| generator | EJ-120 | N/A | EJ-097 | The ultrasonic generator EJ-120 was cleared | |
| for marketing in K140990 (PIEZON 707 BIK | |||||
| and PIEZON 707 BIK LED). | |||||
| Ultrasound Max | |||||
| output power | 8 W | N/A | 8W (using the handpiece) | Same | |
| Substantial Equivalence Table | |||||
| Item for Comparison | Proposed Device | ||||
| (AIRFLOW Prophylaxis Master) | Proposed Device | ||||
| (AIRFLOW One) | Predicate Device | ||||
| (AIR-FLOW MASTER PIEZON) | Variations | ||||
| Ultrasound | |||||
| Frequency | 24 to 32 kHz | N/A | 24 to 32 kHz | Same | |
| Operating Mode | Continuous Operation | Continuous Operation | Continuous Operation | Same | |
| Flow rate | |||||
| adjustment | Mechanical regulator | Mechanical regulator | Touch panel | Equivalent | |
| Water delivery | • One irrigating liquid bottle for ultrasonic | ||||
| scaling treatment | • One irrigating liquid bottle | • One irrigating liquid bottle for ultrasonic | |||
| scaling treatment | Equivalent | ||||
| system | • Connection to external water supply for | ||||
| both ultrasonic scaling and air-polishing | |||||
| treatment | • Connection to external water supply | • Connection to external water supply for air- | |||
| polishing treatment | |||||
| Waterlines | |||||
| reprocessing | Integrated | Integrated | Manual | Equivalent | |
| Software | ES-087 | ||||
| ES-091 | |||||
| ES-125 | |||||
| ES-046 | ES-087 | ||||
| ES-091 | |||||
| ES-125 | ES-029-030 | ||||
| ES-035 | |||||
| ES-036A | Equivalent | ||||
| Foot pedal | Wireless or wired | Wireless or wired | Wired | Equivalent | |
| Components | • Control Unit | ||||
| • Powder chambers | |||||
| • Irrigation liquid bottle | |||||
| • Foot pedal | |||||
| • AIR-FLOW Handpiece | |||||
| • PERIO-FLOW Handpiece | |||||
| • PERIO-FLOW Nozzle marked | |||||
| • Piezon Handpiece LED | |||||
| • Instruments | • Control Unit | ||||
| • Powder chambers | |||||
| • Irrigation liquid bottle | |||||
| • Foot pedal | |||||
| • AIR-FLOW Handpiece | |||||
| • PERIO-FLOW Handpiece | |||||
| • PERIO-FLOW Nozzle marked | • Control Unit | ||||
| • Powder chambers | |||||
| • Irrigation liquid bottle | |||||
| • Foot pedal | |||||
| • AIR-FLOW Handpiece | |||||
| • PERIO-FLOW Handpiece | |||||
| • PERIO-FLOW Slim Nozzle | |||||
| • Piezon Handpiece LED | |||||
| • Instruments | The PERIO-FLOW Nozzle Marked was | ||||
| cleared for marketing in K171174 (PERIO- | |||||
| FLOW nozzle). | |||||
| Prophylaxis | |||||
| Powders for Use | |||||
| with System | • PERIO (Glycine) | ||||
| • SOFT (Glycine) | |||||
| • CLASSIC (Sodium Bicarbonate) | |||||
| • PLUS (Erythritol) | • PERIO (Glycine) | ||||
| • SOFT (Glycine) | |||||
| • CLASSIC (Sodium Bicarbonate) | |||||
| • PLUS (Erythritol) | • PERIO (Glycine) | ||||
| • SOFT (Glycine) | |||||
| • CLASSIC (Sodium Bicarbonate) | |||||
| • PLUS (Erythritol) | Same |
Table 5-1. Comparison Table for Determination of Substantial Equivalence
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7. Summary of Non-Clinical Performance Testing as Basis for Substantial Equivalence
Testing was performed to verify compliance of the AIRFLOW Prophylaxis Master and AIRFLOW One with the following standards:
- ISO 14971: 2007, "Medical devices Application of risk management to . medical devices"
- ISO 17664: 2004, "Sterilization of medical devices Information to be ● provided by the manufacturer for the processing of resterilizable medical devices"
- ISO 17665-1: 2006, "Sterilization of health care products Moist heat Part . 1: Requirements for the development, validation and routine control of a sterilization process for medical devices"
- ANSI/AAMI ST79: 2010 / A1:2010 / A2:2011 / A3:2012 / A4:2013, . "Comprehensive guide to steam sterilization and sterility assurance in health care facilities"
- ANSI/AAMI ES60601-1: 2005/(R)2012/A1:2012, "C1:2009/(R)2012 and . A2:2010/ (R) 2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)"
- IEC 60601-1-2: 2014, "Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
- IEC 80601-2-60:2012, "Medical electrical equipment Part 2-60: Particular . requirements for the basic safety and essential performance of dental equipment"
- IEC 60601-1-6: 2013, "Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usabilitv"
- IEC 62304: 2015, "Medical device software Software life cycle processes" .
- ISO 15223-1: 2016, "Medical devices Symbols to be used with medical ● device labels, labelling, and information to be supplied - Part 1: General requirements"
- ISO 10993-1: 2009, "Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]"
- . ISO 7405: 2008, Dentistry - "Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]"
- ISTA 2A: 2011. "Packaged-Products 150lb (68 kg) or less" .
The results of this testing confirm that the AIRFLOW Prophylaxis Master and AIRFLOW One are safe and effective for the indications for use described in Section 4.
8. Summary of Clinical Testing as Basis for Substantial Equivalence
No clinical testing was conducted for this submission.
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9. Summary of Other Information
No other information is available.
10. Conclusions Drawn from Non-Clinical and Clinical Tests
Based on the information and supporting documentation provided in the premarket notification, the EMS AIRFLOW Prophylaxis Master and AIRFLOW One are substantially equivalent to the cited predicate device. Testing demonstrates that the EMS AIRFLOW Prophylaxis Master and AIRFLOW One fulfill prospectively defined design and performance specifications.