(148 days)
No
The 510(k) summary describes a mechanical dental device for air-polishing and subgingival cleaning. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of these technologies. The device description focuses on the physical components and mechanism of action.
Yes
The device is intended for non-surgical removal of subgingival plaque in patients with periodontal disease and peri-implantitis, which are therapeutic indications. It is used to treat existing conditions rather than solely for diagnosis or prevention.
No
The device is described as being for "non-surgical removal of subgingival plaque" and "cleaning of teeth," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including an operating unit, handpieces, powder chambers, footpedal, and connections for external water and air supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-surgical removal of subgingival plaque in periodontal pockets. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a dental air-polishing unit used for cleaning. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to physically remove plaque, which is a treatment/procedural action.
N/A
Intended Use / Indications for Use
The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.
The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Product codes
EFB
Device Description
The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing provided in this premarket notification includes electrical safety, electromagnetic compatibility, performance testing and clinical data. Test results demonstrate that the EMS AIR-FLOW MASTER fulfills the prospectively defined performance specifications and can be used safely and effectively for subgingival cleaning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
FEB 1 8 2009
510(k) Summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA EMS AIR-FLOW MASTER
1. SPONSOR
. الخ
E.M.S. ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy 022 994 47 00 Telephone:
Date Prepared: February 5, 2009
2. DEVICE NAME
| Proprietary Name: | EMS AIR-FLOW MASTER |
|---|---|
| Common/Usual Name: | Airbrush/Dental handpiece |
| Classification Name: | Airbrush and accessories/Dental handpiece and accessories |
3. PREDICATE DEVICES
- Electro Medical Systems S.A., AIR-FLOW MASTER STANDARD (K073284) o
4. INTENDED USE
The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.
The EMS AIR-FLOW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
DEVICE DESCRIPTION 5.
The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW
1
CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed EMS AIR-FLOW MASTER is similar in design and materials to the predicate EMS AIR-FLOW MASTER STANDARD. The proposed device is supplied with a flexible thermoplastic nozzle that allows the device to be used for subgingival cleaning of periodontal pockets.
Both the proposed EMS AIR-FLOW MASTER and predicate EMS AIR-FLOW MASTER STANDARD are intended for the cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. However, the proposed AIR-FLOW MASTER is supplied with a flexible, thermoplastic nozzle, which allows the indications for the device to be extended to include subgingival cleaning of periodontal pockets.
Both the proposed EMS AIR-FLOW MASTER and the predicate EMS AIR-FLOW MASTER STANDARD dental air-polishing unit consist of an operating unit, air pressure powered handpiece cords, powder chambers, handpieces, prophylaxis powder, multifunction footpedal and connections for external water and air supply. The AIR-FLOW MASTER PERIO-FLOW handpiece is specially designed for subgingival cleaning of periodontal pockets.
Testing provided in this premarket notification includes electrical safety, electromagnetic compatibility, performance testing and clinical data. Test results demonstrate that the EMS AIR-FLOW MASTER fulfills the prospectively defined performance specifications and can be used safely and effectively for subgingival cleaning. The similarities in intended use, operational characteristics, and functional technological characteristics between the AIR-FLOW MASTER and the AIR-FLOW MASTER STANDARD lead to a conclusion of substantial equivalence between the proposed and predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
E.M.S Electro Medical Systems S.A. C/o Dr. Cynthia J. M. Nolte Senior Regulatory Affairs Consultant Medical Device Consultants. Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
FEB 1 8 2009
K082791 Trade/Device Name: EMS AIR-FLOW MASTER Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: EFB Dated: February 5, 2009 Received: February 6, 2009
1991 - 1994 -
Dear Dr. Nolte:
" Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -Dr. Nolte
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your.Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony V. Marchese, M.D.
Ginette Y. Michaud, M Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K082791
Device Name:
EMS AIR-FLOW MASTER
Indications for Use:
The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.
The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruane
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081729
Electro Medical Systems, Air-Flow Master Additional Information - K082791