(119 days)
This device is a dental bone cutting instrument performing operations in the field of oral surgery.
SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental prosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer. The equipment consists of a console including an electronic control circuit and an ultrasound control circuit, a piezoelectric handpiece and a peristaltic pump. Suitable tips are mounted to the piczoelectric handpiece. The system is based on a sophisticated ultrasvund control structure, which by means of current measurement, carries out electrical resonance handpiece control. All operations are displayed and controlled by a card through a monitor and a keyboard. The integrated pump is used to transport the sterile coolant from its vessel to the preparation point.
This is a 510(k) premarket notification for a medical device (K083560, SURGYBONE). This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a ground truth.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them. The document focuses on demonstrating that the SURGYBONE is substantially equivalent to already legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Specifically, the document states:
- "The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. The proposed and the predicated devices are substantially equivalent."
Without a clinical study comparing the SURGYBONE to a predefined set of acceptance criteria, there is no information available for the tables and points requested.
{0}------------------------------------------------
CONFIDENTIAL
510(K) SUMMARY
APR - 1 2009
This Summary of Safety and Effectiveness is in accordance with the requirements of:
- Device Description
SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental prosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
The equipment consists of a console including an electronic control circuit and an ultrasound control circuit, a piezoelectric handpiece and a peristaltic pump. Suitable tips are mounted to the piczoelectric handpiece.
The system is based on a sophisticated ultrasvund control structure, which by means of current measurement, carries out electrical resonance handpiece control. All operations are displayed and controlled by a card through a monitor and a keyboard. The integrated pump is used to transport the sterile coolant from its vessel to the preparation point.
The Surgybone
Intended use -
SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of oral surgery, by means of ultrasound vibrations produced by a piezoelectric transducer.
- Summary of Substantial Equivalence Discussion -
- UBS&UDD manufactured by ITALIA MEDICA s.r.l. K080220
PIEZOTOME manufactured by SATELEC K(060274
PIEZOSURGERY manufactured by PIEZOSURGERY, INC. (distributed in K043408 USA by MECTRON s.p.a.)
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. The proposed and the predicated devices are substantially equivalent.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Silfradent S.R.L. C/O Ms. Claude Berthoin President Denterprise International, Incorporated 110 East Granada Boulevard, Suite 208 Ormond Beach, Florida 32176
APR - 1 2009
Re: K083569
Trade/Device Name: SURGYBONE Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: March 25, 2009 Received: March 26, 2009
Dear Ms. Berthoin:
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.
{2}------------------------------------------------
Page 2 - Ms. Berthoin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runore
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
INDICATION FOR USE
Applicant: SILFRADENT s.r.l.
08356 9 510(k) Number (if known):
Device Name: SURGYBONE
Indication For Use:
This device is a dental bone cutting instrument performing operations in the field of oral surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Susan Rusper
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08-3569
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.