Abutment and Prosthetic Accessories to the Iti Dental Implant System
FDA 510(k) K022859 · Straumann USA
510(k) numberK022859
Submission
- Device name
- Abutment and Prosthetic Accessories to the Iti Dental Implant System
- Applicant
- Straumann USA
Waltham, MA, US - Received
- August 28, 2002
- Decision date
- September 19, 2002
- 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 |
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| 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 |
|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA)NHA · Traditional | 11/11/2024SE |
| K203753 | Straumann Surgical CassettesKCT · Traditional | 07/29/2021SE |
| K202942 | Straumann 4 mm Short ImplantsDZE · Traditional | 02/08/2021SE |
| K192401 | Straumann Screw-Retained AbutmentsNHA · Traditional | 04/06/2020SE |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional | 06/17/2019SE |
| K171784 | Straumann Dental Implant SystemDZE · Traditional | 01/19/2018SE |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional | 03/08/2017SE |
| K151590 | Straumann RN Gold Abutment for BridgeNHA · Traditional | 03/04/2016SE |
| K151328 | PURE Ceramic ImplantsDZE · Traditional | 01/11/2016SE |
| K150899 | Straumann CARES Titanium Alloy (TAN) AbutmentNHA · Traditional | 09/16/2015SE |
Questions and answers
When was Abutment and Prosthetic Accessories to the Iti Dental Implant System cleared by the FDA?
Abutment and Prosthetic Accessories to the Iti Dental Implant System (K022859) received a 510(k) decision of Substantially Equivalent on September 19, 2002, 22 days after the submission was received.
What is the product code of K022859?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.