Astra Tech Implant System
FDA 510(k) K111287 · Astra Tech AB
510(k) numberK111287
Submission
- Device name
- Astra Tech Implant System
- Applicant
- Astra Tech AB
San Diego, CA, US - Received
- May 6, 2011
- Decision date
- September 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K121810 | Osseospeed Angled Abutment EvNHA · Traditional | 01/23/2013SE |
| K122078 | Lofric Primo, Lofric Hydro-KitEZD · Traditional | 10/31/2012SE |
| K120414 | Osseospeed PlusDZE · Traditional | 07/31/2012SE |
| K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaNHA · Traditional | 07/05/2012SE |
| K113424 | Lofric Single Use Urinary CatheterEZD · Traditional | 04/17/2012SE |
| K113003 | Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant…NHA · Traditional | 03/01/2012SE |
| K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantNHA · Traditional | 12/01/2011SE |
| K101005 | Astra Tech Implant System, New ComponentNHA · Special | 06/21/2011SE |
| K110640 | Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentNHA · Traditional | 06/10/2011SE |
| K110356 | Atlantis Crown Abutment, Atlantis Gemini +(Tm) AbutmentNHA · Traditional | 06/10/2011SE |
Questions and answers
When was Astra Tech Implant System cleared by the FDA?
Astra Tech Implant System (K111287) received a 510(k) decision of Substantially Equivalent on September 26, 2011, 143 days after the submission was received.
What is the product code of K111287?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.