Surgical Drills— 510(k) K200265

Name: FDA 510(k) clearance K200265
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Substantially Equivalent

Implant Direct Sybron Manufacturing, LLC

FDA 510(k) clearance K200265 for Surgical Drills, Substantially Equivalent on 2020-06-30. Applicant: Implant Direct Sybron Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Implant Direct Sybron Manufacturing, LLC
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2020-02-03
Decision date: 2020-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZI

view all

K253655 — Angled Screwdriver MED (M-SD090)2026-07-31
K253776 — Implantmed Plus II & Piezomed Plus II Module2026-06-18
K254163 — VarioSurg 42025-12-23
K242432 — MT-Bone2024-08-19
K240340 — Surgical Drive System (Model: ES70, ES90, E8)2024-07-18

More clearances from Implant Direct Sybron Manufacturing, LLC

view all

K231087 — Guided Surgery Kit2023-08-16
K223535 — SMARTbase Abutment System2023-06-20
K222211 — Implant Direct Dental Implant Systems Portfolio - MR Conditional2023-02-02
K202524 — Standard Sterilizable Tray2021-01-28
K201553 — Simply Iconic Implants2021-01-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.