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Nobel Biocare N1

Also known as: N1, Nobel Biocare N1 TiUltra, N1 TCC

A Nobel Biocare implant system built around a trioval implant body and the Trioval Conical Connection, placed with the OsseoShaper instrument at low speed without irrigation.

Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.

Quick facts

Current statusCurrent. Nobel Biocare N1 is listed in the implant catalogue, and the Trioval Conical Connection is a distinct connection filter within it.Manufacturer-reported[1][2]
Implant levelManufacturer documentation not located(Nobel Biocare describes a trioval implant neck and a two-piece N1 Base placed at surgery, but the pages reviewed do not classify the implant as bone level or tissue level.)
Body geometryTrioval implant neck, which Nobel Biocare states reduces stress on cortical bone and gives a consistent implant wall width around the circumference.Manufacturer-reported[3]
Thread designManufacturer documentation not located
Apex designManufacturer documentation not located
MaterialManufacturer documentation not located
SurfaceTiUltra on the implant; the Xeal surface is used on the N1 Base and multi-unit abutments.Manufacturer-reported[3]
ConnectionTrioval Conical Connection (TCC). Nobel Biocare catalogues it as a separate connection type from its internal conical connection.Manufacturer-reported[3][1]
Platform switchingNobel Biocare states that the trioval implant and TCC together give a 360° consistent implant wall width and a platform shift, but the pages reviewed do not give the shift dimension.Manufacturer-reported[3]
Available diametersCatalogued on NP ∅ 3.5 mm, RP ∅ 4.0 mm and RP ∅ 4.8 mm platforms.Manufacturer-reported[2]
Available lengths7, 9, 11, 13 and 15 mm.Manufacturer-reported[2]Not every length is offered on every platform.

Overview

N1 is the most deliberately different system Nobel Biocare currently sells, and the difference is in the surgery rather than the restoration. Instead of a sequence of drills at high speed with saline cooling, the site is shaped by an OsseoShaper turning at around 50 rpm with no irrigation, which is intended to preserve rather than remove bone. The implant itself is trioval rather than round, so its wall thickness stays constant around the circumference, and it uses the Trioval Conical Connection — a connection unique to N1 and incompatible with the rest of the Nobel range. Because the system is comparatively recent, the published size range is narrow, and independent long-term outcome data is still limited compared with older Nobel lines.

Technology

Clinical positioning

What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.

Nobel Biocare describes N1 as intended for immediate placement in extraction sockets, anterior placement, the posterior maxilla with sinus floor elevation, and sites with inadequate vertical bone height.Manufacturer-reported

Further detail

Digital workflowSite preparation uses a two-stage protocol with the OsseoDirector pilot instrument and the OsseoShaper, run at low speed (50 rpm) without irrigation.Manufacturer-reported[3]

Clinical evidence

We have not yet completed a system-specific evidence review for Nobel Biocare N1. Insufficient system-specific evidence How we grade evidence

Similar implant systems

Popular comparisons

The clearances below are held by Nobel Biocare at brand level and cover its implant range, not Nobel Biocare N1 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 →

Other7 records

Registered device establishment in Sweden. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

NumberDeviceHolderDate
9611992NOBEL BIOCARE AB
3006540014NOBEL BIOCARE DISTRIBUTION CENTER BV
3008693672Nobel Biocare Services AG
3005031178NOBEL BIOCARE PROCERA, LLC
2027971NOBEL BIOCARE USA, LLC
9611993NOBEL BIOCARE AB, PRODUKTION
1002 device recordsNobel Biocare

FDA 510(k) clearance6 records

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

NumberDeviceHolderDate
K252197Nobel Biocare S Series ImplantsNobel Biocare AB2026-02-18
K212125Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalNobel Biocare AG2021-09-24
K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSNobel Biocare Uas, Inc.2004-08-26
K922805NOBELPHARMA TORQUE CONTROLLERNobelpharma USA, Inc.1993-07-22
K910611NOBELPHARMA CERAONE ABUTMENT SYSTEMNobelpharma USA, Inc.1991-08-16
K905436NOBELPHARMA DRILLING EQUIPMENT DEC 500Nobelpharma USA, Inc.1991-03-04

Clearance records for Nobel Biocare 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 Nobel Biocare.

Sources

Numbers match the citations beside each claim above.

Primary sources

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