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The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm.

Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without tissue reflection.

The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary.

All components are to be used as labeled. Components are not intended to be bent by the clinician.

Altiva Immediate Function Dental Implant

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental implant, stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory information, indications for use, and general controls, but no performance metrics or study details.

Therefore, I cannot provide the requested table and answers to the specific questions regarding acceptance criteria and study data.

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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.

Not Found

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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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 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.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental implant system. This document is a regulatory approval and does not contain any information regarding acceptance criteria, study details, or performance metrics of the device as it relates to clinical outcomes or algorithm performance.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided input. This type of information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided text.

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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.

Not Found

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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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.

Not Found

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.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device