Hybrid Endopore Endosseous Dental Implant
FDA 510(k) K040714 · Innova Corp.
510(k) numberK040714
Submission
- Device name
- Hybrid Endopore Endosseous Dental Implant
- Applicant
- Innova Corp.
Washington, DC, US - Received
- March 18, 2004
- Decision date
- April 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
|---|---|---|
| K984117 | Innova Telescopic DistractorMQN · Traditional | 02/10/1999SE |
| K971196 | Endopore Endosseous Dental Implant SystemDZE · Traditional | 05/08/1997SE |
| K952434 | Endopore Dental Implant AbutmentsDZE · Traditional | 07/19/1995SE |
| K926354 | Endo-Pore Endosseous Dental Implant SystemDZE · Traditional | 02/13/1995SE |
| K915361 | The Body BuggyLYG · Traditional | 12/20/1991SE |
Questions and answers
When was Hybrid Endopore Endosseous Dental Implant cleared by the FDA?
Hybrid Endopore Endosseous Dental Implant (K040714) received a 510(k) decision of Substantially Equivalent on April 9, 2004, 22 days after the submission was received.
What is the product code of K040714?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.