Endure Implant, Model 5108, 5111, 5113, 5114
FDA 510(k) K072660 · Imtec Corp.
510(k) numberK072660
Submission
- Device name
- Endure Implant, Model 5108, 5111, 5113, 5114
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- September 21, 2007
- Decision date
- December 12, 2007
- 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 |
More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K081653 | Mdi Mii One-Piece Implant, 2.9MMDZE · Traditional | 09/19/2008SE |
| K081347 | Iluma VisionLLZ · Traditional | 05/28/2008SE |
| K053046 | Iluma Orthocat/DentalcatJAK · Abbreviated | 11/08/2005SE |
| K043226 | Endure Implant, Models 3508, 4308, 3520, 4320DZE · Traditional | 01/13/2005SE |
| K042289 | Mdi OrthoDZE · Traditional | 09/15/2004SE |
| K033432 | Lexatite Quick AcrylicEBG · Traditional | 01/15/2004SE |
| K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-XxDZE · Traditional | 08/12/2003SE |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314DZE · Traditional | 04/23/2003SE |
| K024044 | Saber Tech Implants SystemDZE · Traditional | 02/21/2003SE |
| K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8DZE · Traditional | 12/03/2002SE |
Questions and answers
When was Endure Implant, Model 5108, 5111, 5113, 5114 cleared by the FDA?
Endure Implant, Model 5108, 5111, 5113, 5114 (K072660) received a 510(k) decision of Substantially Equivalent on December 12, 2007, 82 days after the submission was received.
What is the product code of K072660?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.