Who is the manufacturer of RONDOFLEX PLUS 360?

Kavo America Corporation filed the 510(k) submission for RONDOFLEX PLUS 360 (K042872).

What is the FDA product code for RONDOFLEX PLUS 360?

KOJ. It is classified under 21 CFR 872.6080 as a Class 2 device in the Dental panel.

What is the regulatory pathway for RONDOFLEX PLUS 360?

510(k) clearance (submission type: Special).

What are the predicate devices for RONDOFLEX PLUS 360?

KaVo Corund Handpiece 2013 (K002708); Velopex Aquacut Fluid Abrasion Unit (K024105); Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675).

Who can help prepare an FDA 510(k) submission like RONDOFLEX PLUS 360?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RONDOFLEX PLUS 360

K042872 · Kavo America Corporation · KOJ · Nov 23, 2004 · Dental

Device Facts

Record ID	K042872
Device Name	RONDOFLEX PLUS 360
Applicant	Kavo America Corporation
Product Code	KOJ · Dental
Decision Date	Nov 23, 2004
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.6080
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Air abrasion system; uses high-speed alumina particles (27 or 50 μ) accelerated in air jet to remove tooth material. Modification of KaVo Corund Handpiece 2013; adds water to abrasive stream. Used in dental clinics by licensed professionals. Connects to standard MULTIflex couplings. Healthcare provider directs handpiece at tooth surface; abrasive action cleans/prepares enamel/dentine for restorations or bonding. Benefits include efficient surface preparation and cleaning without mechanical bur vibration.

Clinical Evidence

No clinical data provided. Substantial equivalence based on indications for use and internal validation studies.

Technological Characteristics

Air abrasion handpiece; alumina powder (27/50 μ) and water delivery. Drive pressure 3.2-6.0 bar; water pressure 1.5 ± 1.0 bar. Water flow rate ~40 cm3/min. Connects to MULTIflex couplings. Sterilization via autoclave.

Indications for Use

Indicated for dental professionals to perform fissure preparation, micro-mechanical retention creation for adhesive restorations, small carious defect preparation, enamel discoloration removal, adhesive residue removal from dental prosthetics, and bracket surface preparation. Prescription use only.

Regulatory Classification

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.

Special Controls

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.”

Predicate Devices

KaVo Corund Handpiece 2013 (K002708)
Velopex Aquacut Fluid Abrasion Unit (K024105)
Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675)

Related Devices

K990060 — MACH 7 · Kreativ, Inc. · Jun 15, 2000
K955050 — JETSTREAM CAVITY PREPARATION SYSTEM · Dove Systems, Inc. · Mar 7, 1996
K974655 — PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM · Prep Technology Corp. · Jul 9, 1998
K980216 — KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 · Kreativ, Inc. · Jun 16, 1998
K984415 — S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F · S.S. White Technologies, Inc. · Sep 29, 1999

Submission Summary (Full Text)

{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 - 1. Identification of the Device: Proprietary-Trade Name: KaVo RONDOflex® plus 360 Handpiece Classification Name: Airbrush Product Codes KOJ Common/Usual Name: Airbrush - 2. Equivalent legally marketed device: KaVo Corund Handpiece 2013 (K002708); Velopex Aquacut Fluid Abrasion Unit (K024105) and Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675). The latter two units use water with the airbrush. . - 3. 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. - 4. 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 | - 6. 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 ________________________________________________________________________________________________________________________________________________________________ Page 1 of 1