(128 days)
Not Found
No
The device description and intended use describe a mechanical device for cleaning teeth using air, water, and powder, with no mention of AI or ML capabilities.
No.
The device is used for cleaning and polishing teeth, which is a maintenance procedure, not a therapeutic treatment aimed at curing or alleviating a disease.
No
The device is described as being used for cleaning and polishing teeth, and preparing surfaces for dental procedures, which are interventional or preparatory actions, not diagnostic ones.
No
The device description clearly outlines physical components like air and water lines, a powder chamber, and a nozzle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AirFlow handy is a dental handpiece used for the physical cleaning and polishing of teeth and dental prosthetics. It operates by projecting a mixture of air, water, and powder onto the surface.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is entirely external and mechanical.
The provided information clearly describes a device used for a physical dental procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
- implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
- crowns and bridges .
- fixed bands and brackets prior to placement on orthodontic appliances. .
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
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 was performed to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. Connection-integrity testing demonstrated that the connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar.
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
7 1999 OCT
APPENDIX B
Modified 510(k) Summary
.
· .
9/9/99
1
510(k) Summary for AirFlow handy
1. SPONSOR
Electro Medical Systems SA Ch. Vuarpillière 31 1260 Nyon SWITZERLAND
Contact Person: Daniel Rochat, Operational Director 41-22-994 47 18, 41-22-994 47 00 Telephone:
Date Prepared: September 9, 1999
2. DEVICE NAME
Proprietary Name: AirFlow handy Common/Usual Name: Dental handpiece Dental handpiece and accessories Classification Name:
3. PREDICATE DEVICES
4. DEVICE DESCRIPTION
The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
2
5. INTENDED USE
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
- implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
- crowns and bridges .
- fixed bands and brackets prior to placement on orthodontic appliances. .
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Both the proposed device and the substantially equivalent devices are intended for use in the cleaning and polishing of teeth. Unlike the predicate AirFlow SII, the proposed device does not function as a scaler.
The operational principle of the proposed device is identical to that of the AirFlow SII and the Prophyflex 2. The cleaning and polishing action is produced by the projection of air, water, and bicarbonate powder onto the tooth surface. The proposed device is supplied with a fixed nozzle or a rotating nozzle with a tip angle of 90° or 120°. The fixed AirFlow nozzle is identical to the nozzle used for the predicate AirFlow SII. The rotating AirFlow nozzles are identical to the predicate AirFlow SII except for minor design modifications to permit the tip to rotate. The rotating nozzle is also similar to the Prophyflex II nozzle.
The AirFlow handy differs from the AirFlow SII in size and in the location of the powder chamber. The proposed AirFlow handy is smaller than the AirFlow SII, and, like the Prophyflex 2, the powder chamber has been incorporated into the body of the device.
The differences between the proposed and predicate devices are restricted to minor differences in size, design, and materials and do not impact the safety or effectiveness of the device.
3
7. PERFORMANCE TESTING
Testing was performed to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. Connection-integrity testing demonstrated that the connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar.
9/9/99
4
Image /page/4/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 figures, possibly representing health, family, and community.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1999
Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K991857 AirFlow Handy Trade Name: Requlatory Class: ने Product Code: EFB 1999 Dated: September 9, Received: September 10, 1999
Dear Dr. Nolte:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Dr. Nolte
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number: K991857
Device Name: AirFlow handy
Indications for Use:
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
- implant abutments and teeth prior to treatments such as shade matching, . fluoridation, and bleaching
- crowns and bridges
- fixed bands and brackets prior to placement on orthodontic appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B
usem (Division Sign-Off) Divis on of Dental, Infection Control, Divis of of Dental, Infostion
and General Hospital Device 510(k) Number -
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)