(90 days)
Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This fixture is not intended for use in type I bone.
The Nobel Biocare Ebon Fixture™ is an endosseous implant made of grade 1 commercially available titanium and is intended to be placed in the upper or lower jaw bone to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This system also includes 2 bevel drills.
The provided text does not contain information about acceptance criteria, device performance, or a study. The document is a 510(k) summary and approval letter for a dental implant, focusing on substantial equivalence to a predicate device rather than detailed performance study results.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document indicates that the device's technological characteristics are "identical" to predicate products already marketed by Nobel Biocare, and the FDA determined it to be "substantially equivalent." This implies that the device is considered to meet the same safety and effectiveness standards as its predicates, but no specific performance metrics or studies are detailed in this summary.
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Pre-market Notification Page -3-*****************************************************************************************************************************************************************************
Ka7482y
VII. 510(k) Summary of Safety and Effectiveness
MAR 2 4 1998
A. Name and Address
This Summary of Satety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.
B. Name of the Device
This device system consists of various titanium fixtures and two drills.
C. The Predicate Product
The predicate products used in this Pre-market Notification are other components marketed by Nobel Biocare which include the self-tapping MKII fixtures DCA 220, DCA 222, DCA 224, DCA 666, DCA 765 (K945398).
D. Description of Device
The Nobel Biocare Ebon Fixture™ is an endosseous implant made of grade 1 commercially available titanium and is intended to be placed in the upper or lower jaw bone to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This system also includes 2 bevel drills.
E. Intended Use of the Device
Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patients chewing function. This fixture is not intended for use in Type I bone.
F. Comparison of Technological Characteristics
The technological characteristics between the components of the Branemark System® Ebon Fixtures and the corresponding predicate products found in the Branemark System® are identical.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure. The design is composed of several curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1998
Ms. Betsy A. Brown ·Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 Westmont, Illinois 60559
Re : K974828 Trade Name: Branemark System® Ebon™ Fixture Regulatory Class: III Product Code: DZE Dated: December 23, 1997 Received: December 24, 1997
Dear Ms. Brown:
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 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with --the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Ms. Brown
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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 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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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.fdal.gov/cdrh/dsmamain.html".
Sincerely yours,
Tim R. Whiteley
thy A. Ulatows Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | Branemark System® Ebon Fixture |
Indications For Use:
Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This fixture is not intended for use in type I bone.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number ka 7458
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.