(90 days)
For implantation into the fully or partially edentulous ridge for the support of a dental prosthesis or for single tooth replacement, in a single stage surgical procedure.
The product is intended to be implanted with no-load conditions for 8-10 weeks after implantation.
Not Found
The provided text is a 510(k) premarket notification for a dental implant system. This type of document issues a substantial equivalence determination for a medical device but does not contain acceptance criteria or study results for device performance.
Therefore, I cannot extract the requested information based on the provided text. The document primarily focuses on regulatory approval and classification, not detailed performance metrics and supporting studies.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure. The bird is depicted with three horizontal lines forming its body and wings, and a curved line representing its head and beak.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Mr. Rodney J. Shaughnessy Regulatory Affairs Biomedical Implant Technology, Incorporated 206 King Street Saint Catherinese, Ontario, CANADA
Re: K013383
Trade/Device Name: BioHex One-Piece One Stage Dental Implant System Regulation Number: 872.3640 Regulation Name: Dental Implant Regulatory Class: III Product Code: DZE Dated: October 11, 2001 Received: October 12, 2001
Dear Mr. Shaughnessy:
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.
{1}------------------------------------------------
Page 2 - Mr. Shaughnessy
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 mean that I Dri mas made a determind regulations administered by other Federal agencies. of the Act of ally I oderal banates and see requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 OF R Part 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are qt 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 This letter will and w you to occall mailering of substantial equivalence of your device to 310(K) promises nounce to 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 If you desire specific as a rear 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may be counter 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.
Susan Kanne
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo and contact information for Biomedical Implant Technology Inc. The logo includes a stylized graphic to the left of the company name. The address is listed as 206 King Street, St. Catharines, Ontario, Canada, L2R 3J7, with the telephone number (905) 686-9822 and fax number (905) 682-8496.
510(k) Premarket Notification K013383
CONFIDENTIAL
Monday, January 07, 2002
Product Monograph
Intended use of the device (revised January 7, 2002)
For implantation into the fully or partially edentulous ridge for the support of a dental prosthesis or for single tooth replacement, in a single stage surgical procedure.
The product is intended to be implanted with no-load conditions for 8-10 weeks after implantation.
Susan Runne
് Wision Sign-Off) vision of Dental, Infection Control, - General Hospital Device ... Number _
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.