Certain Prevail Dental Implant
FDA 510(k) K061629 · Implant Innovations, Inc.
510(k) numberK061629
Submission
- Device name
- Certain Prevail Dental Implant
- Applicant
- Implant Innovations, Inc.
Palm Beach Gardens, FL, US - Received
- June 12, 2006
- Decision date
- February 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K062636 | Osseotite, Osseotite Ny, Certain, Certain NT, Prevail, Certain Prevail, XP…DZE · Traditional | 06/01/2007SE |
| K063341 | 3I Osseotite Certain Dental ImplantsDZE · Traditional | 04/30/2007SE |
| K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteDZE · Traditional | 04/24/2007SE |
| K063403 | Conical Angled AbutmentNHA · Traditional | 03/20/2007SE |
| K062432 | Nanotite Dental ImplantsDZE · Traditional | 02/22/2007SE |
| K061969 | Preformance Posts and Temporary CylindersNHA · Special | 07/21/2006SE |
| K061177 | Provide Temporary CylinderNHA · Special | 05/16/2006SE |
| K060291 | Preformance Temporary CylinderNHA · Special | 02/27/2006SE |
| K053170 | Preformance PostsNHA · Traditional | 02/01/2006SE |
| K052648 | Modification to 3I Patient-Specific Dental Abutments and Overdenture BarsNHA · Special | 10/20/2005SE |
Questions and answers
When was Certain Prevail Dental Implant cleared by the FDA?
Certain Prevail Dental Implant (K061629) received a 510(k) decision of Substantially Equivalent on February 23, 2007, 256 days after the submission was received.
What is the product code of K061629?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.