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IMCOR™ implants are indicated to replace missing tooth roots for single tooth, partial tooth 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 surgical drills are intended to be used to create the osteotomy for placement of the dental implant.

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 and restorative system 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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This is a denial. The provided document is a 510(k) clearance letter from the FDA for a dental implant system. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study proving the device meets them. It's a regulatory clearance based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from this document.

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