Surgical Drills
FDA 510(k) K200265 · Implant Direct Sybron Manufacturing, LLC
510(k) numberK200265
Submission
- Device name
- Surgical Drills
- Applicant
- Implant Direct Sybron Manufacturing, LLC
Thousand Oaks, CA, US - Received
- February 3, 2020
- Decision date
- June 30, 2020
- 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 |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| 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 |
| 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 |
| K171326 | Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 04/13/2018SE |
More from Mectron S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K231087 | Guided Surgery KitDZI · Traditional | 08/16/2023SE |
| K223535 | SMARTbase Abutment SystemNHA · Traditional | 06/20/2023SE |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional | 02/02/2023SE |
| K202524 | Standard Sterilizable TrayKCT · Traditional | 01/28/2021SE |
| K201553 | Simply Iconic ImplantsDZE · Traditional | 01/22/2021SE |
| K200858 | Mini Sterilizable TrayKCT · Traditional | 08/06/2020SE |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…DZE · Traditional | 06/25/2020SE |
| K192218 | Custom Legacy and Custom InterActive Titanium AbutmentsNHA · Traditional | 05/08/2020SE |
| K191458 | Legacy SMARTBase AbutmentsNHA · Traditional | 10/10/2019SE |
| K181359 | InterActive SMARTBase AbutmentsNHA · Traditional | 08/15/2018SE |
Questions and answers
When was Surgical Drills cleared by the FDA?
Surgical Drills (K200265) received a 510(k) decision of Substantially Equivalent on June 30, 2020, 148 days after the submission was received.
What is the product code of K200265?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.