(68 days)
The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.
Not Found
This document is an FDA 510(k) clearance letter for the X-TIP Intraosseous Perforator. It primarily addresses the regulatory approval process and states the device's intended use. It does not contain any information regarding specific acceptance criteria for device performance or a study proving that the device meets such criteria.
Therefore, I cannot provide the requested information. The letter only confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail performance data or studies.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re : K990511 X-TIP Intraosseous Perforator Dated: March 30, 1999 Received: April 1, 1999 Classification Regulation Name: Dental, Needle Regulatory Class: I Product Code: DZM
Dear Mr. Schiff:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Schiff
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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamajm.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known):
Not assigned yet
Device Name:
ﺮ ﺍ
X-TIP
Indications for Use:
The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)
Suvar Runnes
Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
§ 872.4730 Dental injecting needle.
(a)
Identification. A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.