Endosseous Dental Implant & Accessories
FDA 510(k) K955281 · The Straumann Co.
510(k) numberK955281
Submission
- Device name
- Endosseous Dental Implant & Accessories
- Applicant
- The Straumann Co.
Cambridge, MA, US - Received
- November 16, 1995
- Decision date
- March 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K041070 | Straumann Temporary CopingNHA · Traditional | 07/23/2004SE |
| K040646 | Straumann GranulesLYC · Traditional | 05/03/2004SE |
| K040469 | The Straumann Ortho Implant SystemOAT · Traditional | 04/30/2004SE |
| K993862 | Modus Sagittal Split PlateJEY · Traditional | 12/29/1999SE |
| K962023 | Plastic Protection Healing CapsDZE · Traditional | 08/15/1996SE |
| K960634 | Titanium Healing CapsDZE · Traditional | 06/18/1996SE |
| K955369 | MemfixDZL · Traditional | 01/23/1996SE |
| K941393 | Iti Angled AbutmentDZE · Traditional | 06/14/1995SE |
| K943720 | Iti Transversal Screwing SystemDZE · Traditional | 03/24/1995SE |
| K931993 | Iti Distance SystemDZE · Traditional | 04/26/1994SE |
Questions and answers
When was Endosseous Dental Implant & Accessories cleared by the FDA?
Endosseous Dental Implant & Accessories (K955281) received a 510(k) decision of Substantially Equivalent on March 15, 1996, 120 days after the submission was received.
What is the product code of K955281?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.