(88 days)
IMCOR implants are indicated to replace missing tooth roots for single tooth, partial and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process. The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace. All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.
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The provided document is a 510(k) premarket notification approval letter for the IMCOR™ HA Coated Dental Implants. This type of document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not a review of clinical efficacy or performance studies with detailed acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this document.
The document only states the indications for use of the IMCOR™ implants, which are:
- To replace missing tooth roots for single tooth, partial, and fully edentulous patients.
- The cover screw is used to protect the top of the implant and internal threads during healing.
- The system is designed to become an osseointegrated prosthesis allowing attachment of prosthodontic appliances.
The FDA's finding of substantial equivalence means they determined that the IMCOR™ device is as safe and effective as a predicate device already on the market, based on the information submitted by the manufacturer. This typically involves comparing features, materials, and intended use, not necessarily providing a new, independent performance study with defined acceptance criteria in the approval letter itself.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
IMCOR™ C/O Robert S. Ura, DDS 5763 Long Brake Circle Edina, Minnesota 55439
Re: K974126 IMCOR™ 3.75 and 5.00mm Externally Hexed, Trade Name: Self-Tapping HA Coated Screw Implants with Cover Screw Regulatory Class: III Product Code: DZE Dated: October 13, 1997 November 3, 1997 Received:
Dear Dr. Ura:
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 reqistration, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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/dsmamain.html".
Sincerely yours,
Alilathrel
thy A. Ulatows Timo Director 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): N/A
IMCCIR HA Coated Dental Implant Device Name:
Indications For Use:
IMCOR implan s are indicated to replace missing tooth roots for single tooth, partial and fully edentulous parients. The cover screw is used to protect the top of the implant and the internal threads during the healing process.
The IMCOR In blant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace.
All component: are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Rumm
(Division Sign-Off) Division of Dental, Info and General Hospi 510(k) Number
Prescription Use _
OR
Over-The-Counter Use
(Per 21 CFR 801-109)
(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.