Cleared Traditional

Surgical Drills (K200265) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200265 · Implant Direct Sybron Manufacturing, LLC · Dental device
Download Printable Device Report (PDF)
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Jun 2020
Decision
148d
Days
Class 2
Risk

K200265 is an FDA 510(k) clearance for the Surgical Drills. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on June 30, 2020 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Implant Direct Sybron Manufacturing, LLC devices

Submission Details

510(k) Number K200265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 12
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K200265.
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Jul 2024
Guided Surgery Kit
K231087 · Implant Direct Sybron Manufacturing, LLC · Aug 2023
TRAUS SUS20
K192561 · Saeshin Precision Co., Ltd. · Jul 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
K192033 · Bennett Jacoby, Dds, Ms, Inc. · Jun 2020
PIEZOTOME CUBE
K172137 · Satelec - Acteon Group · May 2018
Piezosurgery White
K171326 · Mectron S.P.A. · Apr 2018