(47 days)
Not Found
No
The device description and intended use focus on mechanical action (air, water, powder projection) and do not mention any computational or learning capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is intended for cleaning and polishing teeth, which are prophylactic and cosmetic procedures rather than therapeutic.
No
The device is intended for cleaning and polishing teeth, removing deposits and discoloration, which are therapeutic and preparatory functions, not diagnostic.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the physical cleaning and polishing of teeth in vivo (within the body). It removes deposits and discoloration from the tooth surface.
- Device Description: The description details a hand-held device that projects air, water, and powder onto the tooth surface. This is a mechanical action performed directly on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any such analysis of biological specimens.
The device is a dental handpiece used for a therapeutic and cosmetic procedure performed directly on the patient's teeth.
N/A
Intended Use / Indications for Use
The AirFlow handy is a dental handpiece intended for use in the cleaning and The Fill 10W halls) 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 our be 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)
Not Found
Device Description
The AirFlow handy is a hand-held device containing air and water lines, powder The Alfriow name) is a inflow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the tube willen supplies 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
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 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.
AirFlow SII (K900709), Prophyflex 2, Model 2012 (K973876)
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
510(k) Summary for AirFlow handy
SPONSOR 1.
Electro Medical Systems SA Ch. Vuarpillière 31 1260 Nyon SWITZERLAND
Daniel Rochat, Operational Director Contact Person: 41-22-994 47 18, 41-22-994 47 00 Telephone:
September 9, 1999 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | AirFlow handy |
|---|---|
| Common/Usual Name: | Dental handpiece |
| Classification Name: | Dental handpiece and accessories |
PREDICATE DEVICES 3.
DEVICE DESCRIPTION 4.
The AirFlow handy is a hand-held device containing air and water lines, powder The Alfriow name) is a inflow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the tube willen supplies 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.
1
INTENDED USE ડ.
The AirFlow handy is a dental handpiece intended for use in the cleaning and The Fill 10W halls) 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 our be 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.
Electro Medical Systems Amendment to K991857 EMS AirFlow handy
9/9/99
Page B-2
24
2
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
Electro Medical Systems Amendment to K991857 EMS AirFlow handy
. -
Page B-3
3
Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized lines that resemble a person with outstretched arms.
JUN 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dentsply International Mr. Jeffery P. Lehn Mr. Jeffery 1 : Lornorate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K041141
KU41141
Trade/Device Name: Dentsply Cavitron Jet Wave air Polishing Prophylaxis System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 28, 2004 Received: April 30, 2004
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales one of the device is substantially equivalent (for the reletenced above and nave decemblics tre to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce proct to that have been reclassified in accordance with the provisions of Amendinens, of to devroes that have of the United onot require approval of a premarket the rederal Pood, Drug, und Commons , therefore, market the device, subject to the general approval application (1 mm ). - The general controls provisions of the Act include controls provisions of the Hea. "The girling 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 If your device is classified (been additional controls. Existing major regulations affecting (FMA), it may of subject to fact and of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in ther announcements concerning your device in the Federal Register.
4
Page 2 -- Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S issualled of a basedantines with other requirements
mean that FDA has made a determination that your device the Forders and mean that FDA nas made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regirements, including, but not limited to: registration propotion You must comply with an the Act 3 requirements (21 CFR Part 801); good manufacturing practice and listing (21 CFK Fall 607), laoomig (21 CFR Part 820), and if and 820); and if requirements as set form in the quality systems (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) I his letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. The PDF Intialing or seessification 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), If you desire specific advice for your de at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binastic or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kein Marley
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): K041141
JET WAVE™ SYSTEM Device Name:
Indications for Use
The IET WAVE™ SYSTEM is indicated for air polishing procedures including the removal of a
nd the collection and consembly seebularis; and cleaning tooth surfaces prior to bo The JET WAVE™ SYSTEM is indicated for air polishing procedures medialing the really
variety of extrinsic stains; general prophylaxis; and cleaning tooth surfaces prior to bon sealant procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 2) 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 Fraser
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Der 510(k) Number: