Cleared Traditional

K063468 - THE FUGO BLADE FOR DENTISTRY

K063468 is an FDA 510(k) clearance for THE FUGO BLADE FOR DENTISTRY, manufactured by Medisurg , Ltd.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K063468 · Medisurg , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
153d
Days
Class 2
Risk

K063468 is an FDA 510(k) clearance for the THE FUGO BLADE FOR DENTISTRY. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Medisurg , Ltd. (Norristown, US). The FDA issued a Cleared decision on April 18, 2007 after a review of 153 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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 Medisurg , Ltd. devices

FDA 510(k) Submission Details - K063468

510(k) Number K063468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date April 18, 2007
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
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 - EKZ Unit, Electrosurgical, And Accessories, Dental

All 10
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K063468.
Root ZX3
K213477 · J. Morita USA, Inc. · Aug 2022
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · Coltene/Whaledent, Inc. · Oct 2007
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768 · Wallach Surgical Devices, Inc. · Apr 2000
BI-DENT
K982229 · Valley Forge Scientific Corp. · Aug 1998
ODONTOSURGE 2
K981390 · Periogiene · Jun 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996