Ankylos Dental Implant System
FDA 510(k) K040946 · Friadent GmbH
510(k) numberK040946
Submission
- Device name
- Ankylos Dental Implant System
- Applicant
- Friadent GmbH
Lake Forest, CA, US - Received
- April 12, 2004
- Decision date
- July 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZE
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|---|---|---|---|
| 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 |
|---|---|---|
| K040170 | Friadent Plus Dental Implant SystemsDZE · Traditional | 10/27/2004SE |
| K041509 | Ankylos Dental Implant SystemDZE · Traditional | 08/26/2004SE |
| K032302 | Xive TG AbutmentsDZE · Traditional | 10/02/2003SE |
| K032284 | Xive TG Dental Implant SystemDZE · Special | 08/14/2003SE |
| K032158 | Xive Dental Implant System MultipleDZE · Special | 08/14/2003SE |
| K031674 | Modification to FRIALIT-2 Dental Implant SystemDZE · Special | 08/14/2003SE |
| K024004 | Xive Transgingival Dental Implant SystemDZE · Special | 03/03/2003SE |
| K023799 | Frios AlgiporeLYC · Traditional | 02/05/2003SE |
| K021318 | Xive Dental Implant SystemDZE · Traditional | 07/02/2002SE |
| K013067 | Frialoc Dental Implant SystemDZE · Traditional | 04/09/2002SE |
Questions and answers
When was Ankylos Dental Implant System cleared by the FDA?
Ankylos Dental Implant System (K040946) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 80 days after the submission was received.
What is the product code of K040946?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.