(36 days)
No
The device description and intended use clearly describe a mechanical air abrasion system. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is used for mechanical preparation of tooth surfaces, such as cleaning, abrasion, and removal of material, rather than treating a disease or condition.
No
The device description and intended use primarily describe functions related to preparing tooth surfaces, removing material, and cleaning, rather than identifying or assessing diseases or conditions.
No
The device description clearly states it is an air abrasion system that uses alumina particles and an air jet to remove material from the tooth surface. This involves physical components and mechanisms, not just software.
Based on the provided information, the KaVo RONDOflex® plus 360 Handpiece is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The KaVo RONDOflex® plus 360 Handpiece is an air abrasion system used to physically remove material from the tooth surface for various dental procedures. It operates directly on the tooth within the patient's mouth.
- Intended Use: The intended uses listed are all related to direct dental procedures on the tooth surface, not the analysis of biological specimens.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.
Product codes
KOJ
Device Description
This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.
The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.
Technical data: RONDOflex plus 360
Drive pressure: 3.2 - 6.0 bar
Water pressure: 1.5 ± 1.0 bar Air consumption 5 - 11 1(S.T.P.)/min depending on cannula type The pressure set on the turbine drive is automatically increased by 20%, e.g. from 2.8 to 3.2 bar
Water flow rate: approx. 40 cm3/min
Have the pressures of your unit which have been set by the manufacturer checked regularly by a service engineer in order to ensure satisfactory operation of the instrument. Connection: Can be mounted on all MULTIflex couplings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surface, enamel, dentine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals.
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)
Not Found
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
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended 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.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
2872
NOV 2 3 2004
EXHIBIT 2
510(k) Summary KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Franz, President August 30, 2004
-
- Identification of the Device: Proprietary-Trade Name: KaVo RONDOflex® plus 360 Handpiece Classification Name: Airbrush Product Codes KOJ Common/Usual Name: Airbrush
-
- Indications for Use (intended use): The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.
-
- Description of the Device: This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.
The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.
Technical data: RONDOflex plus 360
Drive pressure: 3.2 - 6.0 bar
Water pressure: 1.5 ± 1.0 bar Air consumption 5 - 11 1(S.T.P.)/min depending on cannula type The pressure set on the turbine drive is automatically increased by 20%, e.g. from 2.8 to 3.2 bar
Water flow rate: approx. 40 cm3/min
Have the pressures of your unit which have been set by the manufacturer checked regularly by a service engineer in order to ensure satisfactory operation of the instrument. Connection: Can be mounted on all MULTIflex couplings.
1
5. Safety and Effectiveness, comparison to predicate device:
| Comparison
Areas | KaVo Corund
Handpiece 2013
(K002708) | Velopex Aquacut
Fluid Abrasion
Unit (K024105) | Sirona Prosmile
Air Polisher and
Prophylaxis
Powder
(K033675) | RONDOflex®
plus 360
Handpiece
(Modified device) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Indications
for use | Preparation for
fissure sealing by
cleaning, opening,
and extending the
fissures; creation of
micro-mechanical
retention for
adhesive
restorations on
enamel and dentine
with subsequent
acid etch technique;
preparation-of small
carious defects;
removal of deep
discolorations in the
enamel; cleaning
and removal of
adhesive residues
from bridges,
crowns, etc.; and,
preparation of
adhesive surfaces of
brackets. | Preparation for pit
and fissure
sealants. Removal
and restoration of
composits (sic)
Cavity
preparation.
Cleaning,
polishing, and
stain removal | Intended for
removing deposits,
plaque, and
staining on all
visible tooth
surfaces as well as
in fissures and
interdental areas.
The ProSmile is
also
intended for the
following
prophylactic
applications:
cleaning teeth
prior to sealing
cleaning teeth
prior to
fluoridation
cleaning teeth
prior to bleaching
cleaning teeth
prior to using
bonding materials | SAME as KaVo
Corund. |
| Abrasive
Material | 27 or 50 μ
corundum powder
(Aluminum oxide) | 29 μ or 53 μ
corundum powder
(Aluminum oxide)
and water | Sirona prophylaxe
powder and water | 27 and 50 μ
corundum powder
and water |
| Sterilization | Autoclave | SAME | SAME | SAME |
-
- Conclusion: In all important respects, the RONDOflex® plus 360 Handpiece is substantially equivalent to the KaVo Corund Handpiece 2013 (K002708), the Velopex Aquacut Fluid Abrasion Unit (K024105)and the Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675). This conclusion is based on indications for use and internal validation studies.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
KAVO America Corporation C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield. Illinois 60015
Re: K042872
Trade/Device Name: RONDOflex® plus 360 Handpiece Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: October 14, 2004 Received: October 26, 2004
Dear Mr. Kamm:
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 - Mr. Kamm
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 (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), please contact the Office of Compliance at (240) 276-0115. 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 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,
Chiu-Liang, Ph.D.
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
4
042872
Indications for Use
510(k) Number (if known):
RONDOflex® plus 360 Handpiece Device Name:_______________
Indications For Use:
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc .; and, preparation of adhesive surfaces of brackets.
Labeling contains the following statement: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
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 Burns
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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