Cleared Traditional

K242263 - TECHFIT DISRP System

K242263 is an FDA 510(k) clearance for TECHFIT DISRP System, manufactured by Techfit Digital Surgery, Inc.. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K242263 · Techfit Digital Surgery, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
132d
Days
Class 2
Risk

K242263 is an FDA 510(k) clearance for the TECHFIT DISRP® System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Techfit Digital Surgery, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on December 11, 2024 after a review of 132 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 Techfit Digital Surgery, Inc. devices

FDA 510(k) Submission Details - K242263

510(k) Number K242263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2024
Decision Date December 11, 2024
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZJ Device Classification - Class 2, Special Controls

Product Code DZJ Driver, Wire, And Bone Drill, Manual
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 - DZJ Driver, Wire, And Bone Drill, Manual

All 23
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K242263.
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