Cleared Traditional

Surgical Drills

K200265 · Implant Direct Sybron Manufacturing, LLC · Dental
Jun 2020
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K200265 is an FDA 510(k) clearance for the Surgical Drills, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on June 30, 2020, 148 days after receiving the submission on February 3, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K200265 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2020
Decision Date June 30, 2020
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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