Mini Sterilizable Tray— 510(k) K200858

Clearance details

Applicant

Implant Direct Sybron Manufacturing, LLC

Product code

Code KCT

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2020-04-01

Decision date

2020-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Thousand Oaks, CA, US

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• Z-2172-2025 — The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.Class II·Ongoing·Implant Direct Sybron Manufacturing LLC·20250501

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200858.