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Implance Bone Level

Also known as: Implance Bone Level Implant

The standard bone-level implant of Turkey’s Implance system, a hybrid tapered/cylindrical fixture with an internal conical connection.

Quick facts

ManufacturerAGS Medikal (Implance)Manufacturer-reported[1]
Implant levelBone levelManufacturer-reported[1]
Body geometryHybrid design — conical (tapered) apex with a cylindrical neckManufacturer-reported[1]
Thread designSemi-aggressive, self-cutting thread with a micro-thread-free neckManufacturer-reported[1][2]
MaterialManufacturer documentation not located(The catalogue states abutment alloys but does not give the titanium grade of the fixture itself.)
SurfaceRBM (Resorbable Blasting Media) roughened surfaceManufacturer-reported[3][1]
ConnectionInternal 11-degree conical (Morse-taper) connection with platform switchingManufacturer-reported[2]
Platform switchingPlatform switching described as moving the implant–abutment junction away from the bone surfaceManufacturer-reported[2][1]
Available diametersØ3.3, Ø3.7, Ø4.3, Ø4.8 and Ø5.5 mmManufacturer-reported[1]
Available lengths8, 10, 12 and 14 mmManufacturer-reported[1]

Overview

The Implance Bone Level implant is AGS Medikal’s standard fixture: a hybrid body that is tapered at the apex and cylindrical at the neck, with a deliberately micro-thread-free collar the company argues lowers the risk of neck bone loss. It uses an internal 11-degree conical connection with platform switching and the RBM surface that runs across the Implance range. Notably, the catalogue documents the abutment alloys but not the titanium grade of the implant body, so that one detail is left unrecorded here rather than assumed.

Technology

Clinical evidence

We have not yet completed a system-specific evidence review for Implance Bone 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 Bone 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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