(24 days)
No
The device description and intended use focus on a mechanical process of air, water, and powder projection for cleaning and polishing teeth. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is used for cleaning and polishing teeth, and preparing them for dental procedures, which are not considered therapeutic treatments.
No
The device is described as an air polisher intended for cleaning and polishing teeth by projecting a mixture of water, air, and bicarbonate powder. Its primary functions are to remove soft deposits and discoloration, prepare teeth for dental procedures, clean implant abutments, clean teeth prior to cosmetic treatments, degrease crowns and bridges, and clean orthodontic appliances. These are all interventional or preparatory functions, not diagnostic ones.
No
The device description clearly outlines a physical device with hardware components (hand-held device, air and water lines, powder chamber, nozzle) that connects to a dental unit. It describes a mechanical process involving air, water, and powder projection. There is no mention of software as the primary or sole component.
Based on the provided information, the EMS AIR-FLOW® handy 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The EMS AIR-FLOW® handy 2 is used for the physical cleaning and polishing of teeth on the patient. It projects a mixture of air, water, and powder directly onto the tooth surface.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's teeth for cleaning, polishing, and preparation for other dental procedures. It does not involve the analysis of specimens taken from the body.
Therefore, the EMS AIR-FLOW® handy 2 falls under the category of a dental device used for treatment and preparation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EMS AIR-FLOW® handy 2 is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching. fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The AIR-FLOW® handy 2 is a modified version of the AirFlow® handy previously cleared under K991857. As with the original AirFlow® handy device, the proposed AIR-FLOW® handy 2 is a turbine-adaptable air polisher that consists of a hand-held device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.
Both the original and the modified device function by connecting to a standard turbine connection of the dental unit, which supplies air and water. The AIR-FLOW® handy 2 is activated when the AIR-FLOW® handy 2 Handpiece is fixed to the turbine connection and the dental unit pedal is pressed. Air enters the proximal end of the device and into the powder chamber where it is mixed with the AIR-FLOW® handy 2 powder. The air/powder mixture leaves the powder chamber and exits the distal end of the device through the AIR-FLOW® handpiece orifice where the air/powder mixture is enveloped by a water spray and directed onto the tooth surface.
The AIR-FLOW® handy 2 offers several improved features including the following:
- the air and powder tubing inside the handpiece is straight instead of curved, which reduces the probability of clogging and facilitates cleaning
- the handpiece is longer, facilitating handling and rotation of the handpiece by the user during the treatment
- a filter and sieve have been added to the air and water lines offering protection of the one-way valve of the connector and the powder chamber. The filters and sieves protect the powder chamber and the one-way valves by preventing any passage of impurities that circulate in the water and air canals. The filter in the air canal prevents back-flow of powder and dissipates humidity by vaporization of any drops of water, which prevents clogging
- the powder chamber capacity has been increased to 23 g from 18 g reducing the number of refills necessary during treatments
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
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)
Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met.
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
§ 872.4200 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
KOJJ119
JUL 2 5 2002
510(k) Summary for Electro Medical Systems SA AIR-FLOW® handy 2 Dental Handpiece
SPONSOR 1.
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy Date Prepared: June 28, 2002
2. DEVICE NAME
| Trade/Proprietary Name: | EMS AIR-FLOW® handy 2 |
|---|---|
| Common/Usual Name: | Dental handpiece |
| Classification Name: | Dental handpiece and accessories |
3. INTENDED USE
The EMS AIR-FLOW® handy 2 is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching. fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
4. DEVICE DESCRIPTION
The AIR-FLOW® handy 2 is a modified version of the AirFlow® handy previously cleared under K991857. As with the original AirFlow® handy device, the proposed AIR-FLOW® handy 2 is a turbine-adaptable air polisher that consists of a hand-held
1
device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.
Both the original and the modified device function by connecting to a standard turbine connection of the dental unit, which supplies air and water. The AIR-FLOW® handy 2 is activated when the AIR-FLOW® handy 2 Handpiece is fixed to the turbine connection and the dental unit pedal is pressed. Air enters the proximal end of the device and into the powder chamber where it is mixed with the AIR-FLOW® handy 2 powder. The air/powder mixture leaves the powder chamber and exits the distal end of the device through the AIR-FLOW® handpiece orifice where the air/powder mixture is enveloped by a water spray and directed onto the tooth surface.
న. BASIS FOR SUBSTANTIAL EQUIVALENCE
The AIR-FLOW® handy 2 has the same intended use as the original AirFlow® handy, which was determined to be substantially equivalent to marketed devices under 510(k) K991857.
The AIR-FLOW® handy 2 utilizes the same technique as the original AirFlow® handy. The AIR-FLOW® handy 2 offers several improved features including the following:
- the air and powder tubing inside the handpiece is straight instead of curved, . which reduces the probability of clogging and facilitates cleaning
- the handpiece is longer, facilitating handling and rotation of the handpiece by . the user during the treatment
- . a filter and sieve have been added to the air and water lines offering protection of the one-way valve of the connector and the powder chamber. The filters and sieves protect the powder chamber and the one-way valves by preventing any passage of impurities that circulate in the water and air canals. The filter in the air canal prevents back-flow of powder and dissipates humidity by vaporization of any drops of water, which prevents clogging
- the powder chamber capacity has been increased to 23 g from 18 g reducing . the number of refills necessary during treatments
2
6. TESTING
Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JUL 2 5 2002
Electro Medical Systems SA C/O Ms. Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K022119
Trade/Device Name: EMS Air-Flow Handy 2 Dental Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 28, 2002 Received: July 1, 2002
Dear Ms. Cullinane:
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.
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.
4
Page 2 - Ms. Cullinane
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 (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.
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 your 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Tim Ulatowski Directo Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: AIR-FLOW® hạndy 2 Dental Handpiece
Indications For Use:
The EMS AIR-FLOW® handy 2 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Dental, Infection Con and General Hospital Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Electro Medical Systems SA Special 510(k) AIR-FLOW® handy 2
June 28, 2002