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Implance Tissue Level

Also known as: Implance Tissue Level Implant

The tissue-level implant of the Turkish Implance system, a transgingival hybrid fixture.

Quick facts

ManufacturerAGS Medikal (Implance)Manufacturer-reported[1]
Implant levelTissue levelManufacturer-reported[1]
Body geometryHybrid tapered/cylindrical body with a transgingival collarManufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceRBM (Resorbable Blasting Media) roughened surfaceManufacturer-reported[3][1]
ConnectionInternal 11-degree conical (Morse-taper) connectionManufacturer-reported[2][1]
Available diametersØ3.7, Ø4.3, Ø4.8 and Ø5.5 mmManufacturer-reported[1]
Available lengths8, 10, 12 and 14 mmManufacturer-reported[1]

Overview

The Implance Tissue Level implant carries a transgingival collar so the implant–abutment junction sits above the bone, which is the defining trait of any tissue-level design and is intended to spare the crestal bone during repeated abutment work. It shares the Implance internal conical connection and RBM surface with the bone-level line. The difference from the bone-level fixture is the collar and where the connection sits, not the underlying surface or connection philosophy.

Technology

Clinical evidence

We have not yet completed a system-specific evidence review for Implance Tissue Level. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by Implance at brand level and cover its implant range, not Implance Tissue Level specifically. We show them here because that is the level at which regulators actually issue them.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance1 record

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.2016-09-12

Clearance records for Implance were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Implance.

Sources

Numbers match the citations beside each claim above.

Primary sources

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