Astra Tech Implant System
Also known as: Astra Tech, Astra Tech Implant System EV, Astra Tech Implant System TX
The implant brand of Swedish origin now owned by Dentsply Sirona, sold today mainly as the Astra Tech Implant System EV.
Key facts
| Manufacturer | DENTSPLY SIRONA Inc.Verified spec[1][2][3] |
|---|---|
| Parent company | DENTSPLY SIRONA Inc., Charlotte, North CarolinaVerified spec[4] |
| Current status | Current — listed among Dentsply Sirona’s implant systems, in both EV and TX generationsVerified spec[1][2] |
| Founded | Manufacturer documentation not located(Astra Tech originated in Sweden; we have not confirmed a founding date for the implant business from a primary source) |
| Manufacturer-described indication | The EV implant family is presented as three implant body designs — Astra Tech Implant EV, PrimeTaper EV and OmniTaper EV — sharing a single prosthetic connection, using a site-specific, crown-down approachManufacturer-reported[2] |
Overview
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]Shop dental products by brand — Dentsply Sirona — DENTSPLY SIRONA Inc.. Accessed 2026-07-21.
- [2]Dental Implant Systems — Dentsply Sirona USA — DENTSPLY SIRONA Inc.. Accessed 2026-07-21.
- [3]Dentsply Sirona acquires MIS Implants — DENTSPLY SIRONA Inc., 2016. Accessed 2026-07-21.
- [4]DENTSPLY SIRONA Inc. — Annual Report on Form 10-K for the year ended 31 December 2025 — U.S. Securities and Exchange Commission (EDGAR), 2026. Accessed 2026-07-21.