Etex Dental Implant System
FDA 510(k) K913417 · Etex Co.
510(k) numberK913417
Submission
- Device name
- Etex Dental Implant System
- Applicant
- Etex Co.
Cambridge, MA, US - Received
- July 31, 1991
- Decision date
- February 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K182107 | CarriGen PFMQV · Special | 08/31/2018SE |
| K132868 | CarricellMQV · Traditional | 02/20/2015SE |
| K141245 | Etex Mixing and Delivery SystemFMF · Traditional | 07/09/2014SE |
| K100883 | CarrigenLYC · Traditional | 12/21/2010SE |
| K102812 | Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special | 12/03/2010SE |
| K101557 | Gamma-Bsm, Beta-Bsm, Equivabone, CarigenMQV · Special | 07/01/2010SE |
| K093447 | CarrigenMQV · Special | 02/18/2010SE |
| K091729 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional | 12/23/2009SE |
| K091607 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneMQV · Traditional | 11/02/2009SE |
Questions and answers
When was Etex Dental Implant System cleared by the FDA?
Etex Dental Implant System (K913417) received a 510(k) decision of Substantially Equivalent on February 19, 1992, 203 days after the submission was received.
What is the product code of K913417?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.