Astra Tech Implant System EV

Also known as: ATIS EV, OsseoSpeed EV, Astra Tech EV

The Dentsply Sirona implant system built on the OsseoSpeed surface, offered in straight, conical and Profile body shapes with a one-position-only interface that also permits six-position indexing.

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Quick facts

Current status	Current. Dentsply Sirona publishes surgical and guided surgery manuals for the system.Manufacturer-reported[1][2]
Implant level	Insufficient evidence(The surgical manual states the osteotomy depth should allow the implant to be level with or slightly submerged relative to the adjacent marginal bone, but does not label the system bone level or tissue level. The two implant instructions for use (IFU 5694 for OsseoSpeed EV and IFU 5699 for Astra Tech Implant EV Profile) do not use either term either. Where Dentsply Sirona writes "bone level" about this system it refers to marginal bone level maintenance, not to an implant classification.)
Body geometry	Three body shapes: OsseoSpeed EV straight, OsseoSpeed EV conical, and OsseoSpeed Profile EV, which has a sloped marginal contour and is offered in ∅ 4.2 and 4.8 mm.Manufacturer-reported[1][2]
Thread design	Manufacturer documentation not located
Apex design	Manufacturer documentation not located
Material	Titanium – Grade 4. Both implant instructions for use give the material as "Titanium – Grade 4" and list allergy or hypersensitivity to commercially pure titanium as a contraindication. This is the substrate; OsseoSpeed is a treatment of that substrate, produced by grit blasting followed by treatment in diluted hydrofluoric acid.Manufacturer-reported[3][4]
Surface	OsseoSpeed. Dentsply Sirona states that implants with the OsseoSpeed surface are especially indicated for soft bone situations where implants with other surface treatments may be less effective.Manufacturer-reported[1]
Connection	An internal interface with one-position-only placement for patient-specific abutments, six-position indexing for prefabricated indexed abutments, and free rotational seating for index-free abutments. Connection sizes are colour-coded across the diameter range.Manufacturer-reported[1]
Platform switching	The guided surgery manual designates OsseoSpeed Profile EV configurations as PS (Platform Switching) and PC (Platform Compatible).Manufacturer-reported[2]
Available diameters	Connection/diameter range ∅ 3.0, 3.6, 4.2, 4.8 and 5.4 mm, colour-coded green, purple, yellow, blue and brown respectively. OsseoSpeed Profile EV is offered in ∅ 4.2 and 4.8 mm.Manufacturer-reported[1]
Available lengths	6, 8, 9, 11, 13, 15 and 17 mm — the Implant Depth Gauge EV is marked to correspond to implant lengths of 6–17 mm. The guided surgery manual narrows the guided-compatible range to 6–15 mm for straight implants and 8–15 mm for conical and Profile implants.Manufacturer-reported[1][2]The two manuals describe different subsets rather than contradicting each other: the guided range is a subset of the freehand range.

Overview

Astra Tech EV is organised around tooth position rather than around a single implant shape, which is why the range contains straight, conical and Profile bodies at the same diameters. The Profile implant is the genuinely unusual one: its marginal contour is sloped rather than flat, so it is designed to follow a sloped ridge without the buccal wall sitting proud of bone. The interface is worth understanding before restoration, because it behaves in three different ways depending on the abutment — one position only for patient-specific abutments, six positions for indexed prefabricated ones, and any position for index-free components. Dentsply Sirona is explicit that the 6 mm implant carries additional precautions, including a preference for a two-stage approach and splinting, which is a useful corrective to the assumption that a short implant is simply a shorter version of a long one.

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.

Dentsply Sirona states that OsseoSpeed EV implants are indicated for immediate placement in extraction sites and in partially or completely healed ridges, using a one- or two-stage surgical procedure, and can be used in an immediate loading protocol.Manufacturer-reported

Further detail

Short implant option	For the 6 mm implant Dentsply Sirona advises considering the widest possible implant, a two-stage surgical approach and splinting, and states that immediate loading may not be appropriate for single-tooth replacement in soft bone or when using a 6 mm implant.Manufacturer-reported[1]

Clinical evidence

We have not yet completed a system-specific evidence review for Astra Tech Implant System EV. Insufficient system-specific evidence How we grade evidence

Similar implant systems

Popular comparisons

The clearances below are held by Astra Tech Implant System at brand level and cover its implant range, not Astra Tech Implant System EV 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) clearance13 records

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

Number	Device	Holder	Date
K111287	ASTRA TECH IMPLANT SYSTEM	Astra Tech AB	2011-09-26
K101732	ASTRA TECH IMPLANT SYSTEM	Astra Tech AB	2011-02-23
K091239	ASTRA TECH IMPLANT SYSTEM	Astra Tech AB	2009-09-22
K053384	FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM	Astra Tech, Inc.	2006-03-24
K041492	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	2004-08-09
K024111	ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED	Astra Tech, Inc.	2003-06-10
K002513	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	2001-01-04
K990304	MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM	Astra Tech, Inc.	1999-07-15
K991053	ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)	Astra Tech, Inc.	1999-06-25
K974738	ASTRA TECH IMPLANT DENTAL SYSTEM	Astra Tech, Inc.	1998-11-19
K974737	ASTRA TECH IMPLANT DENTAL SYSTEM	Astra Tech, Inc.	1998-03-24
K980698	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	1998-03-19
K931767	ASTRA TECH IMPLANTS-DENTAL SYSTEM	Astra Tech, Inc.	1994-02-08

Clearance records for Astra Tech Implant System 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 Astra Tech Implant System.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]Surgical manual — Astra Tech Implant System® EV (32671181-USX-1804) — Dentsply Sirona. Accessed 2026-07-21.
[2]Astra Tech Implant System® EV — Guided surgery manual (32671186-US-1706) — Dentsply Sirona. Accessed 2026-07-21.
[3]Instructions for Use — Astra Tech Implant System® EV, OsseoSpeed™ EV (IFU 5694-EN Rev. 003) — Dentsply Sirona, 2022. Accessed 2026-07-22.
[4]Instructions for Use — Astra Tech Implant System® EV, Astra Tech Implant EV Profile (IFU 5699-EN Rev. 002) — Dentsply Sirona, 2022. Accessed 2026-07-22.