Straumann Guided Instruments
FDA 510(k) K082532 · Straumann USA
510(k) numberK082532
Submission
- Device name
- Straumann Guided Instruments
- Applicant
- Straumann USA
Andover, MA, US - Received
- September 2, 2008
- Decision date
- October 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
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| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K242432 | MT-BoneDZI · Traditional | Mectron S.P.A. | 08/19/2024SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
More from Satelec - Acteon Group
| 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 Straumann Guided Instruments cleared by the FDA?
Straumann Guided Instruments (K082532) received a 510(k) decision of Substantially Equivalent on October 21, 2008, 49 days after the submission was received.
What is the product code of K082532?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.