Axiom PX
FDA 510(k) K161177 · Anthogyr Sas
510(k) numberK161177
Submission
- Device name
- Axiom PX
- Applicant
- Anthogyr Sas
Sallanches, FR - Received
- April 26, 2016
- Decision date
- June 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BLNHA · Traditional | 01/04/2024SE |
| K233264 | Anthogyr INTEGRAL Guided Surgery CassettesKCT · Traditional | 12/22/2023SE |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLDZE · Traditional | 10/16/2023SE |
| K230680 | Anthogyr Surgical CassettesKCT · Traditional | 07/11/2023SE |
| K160730 | Instrument kitsKCT · Traditional | 04/27/2017SE |
| K141450 | Axiom 2.8DZE · Abbreviated | 09/17/2014SE |
| K131066 | Axiom RegDZE · Traditional | 02/21/2014SE |
| K111532 | Montblanc Surgical Contra-Angle and Straight HandpieceEGS · Traditional | 10/07/2011SE |
| K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor UnitEBW · Traditional | 03/23/2011SE |
| K101913 | Anthofit Oi, Anthofit He, Ossfit and AxiomDZE · Abbreviated | 03/11/2011SE |
Questions and answers
When was Axiom PX cleared by the FDA?
Axiom PX (K161177) received a 510(k) decision of Substantially Equivalent on June 15, 2017, 415 days after the submission was received.
What is the product code of K161177?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.