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IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients.

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 by the clinician.

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The provided text is a 510(k) premarket notification letter from the FDA regarding dental implants. It does not contain information about acceptance criteria, device performance, or any studies involving AI, human readers, or ground truth.

Therefore, I cannot provide the requested information based on the given document. The document primarily focuses on:

• Device identification: IMCOR™ 4.00 and 5.00mm Self-Tapping LockTite Implants (various surface coatings).
• Regulatory classification: Class III, product code DZE.
• FDA determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: To replace missing tooth roots for single, partial, and fully edentulous patients, designed to become osseointegrated prostheses.
• Compliance: Subject to general controls, GMP requirements, and other regulations.

To answer your request, I would need a document that describes the clinical or performance studies conducted for the device.

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