Cleared Traditional

K052622 - MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT

K052622 is an FDA 510(k) clearance for MACAN MODEL MC-4A DENTAL ELECTROSURGICA..., manufactured by Macan Engineering Co.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K052622 · Macan Engineering Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
77d
Days
Class 2
Risk

K052622 is an FDA 510(k) clearance for the MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Macan Engineering Co. (Chicago, US). The FDA issued a Cleared decision on December 9, 2005 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052622

510(k) Number K052622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date December 09, 2005
Days to Decision 77 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
51d faster than avg
Panel avg: 128d · This submission: 77d
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 18
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K052622.
Root ZX3
K213477 · J. Morita USA, Inc. · Aug 2022
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · Coltene/Whaledent, Inc. · Oct 2007
THE FUGO BLADE FOR DENTISTRY
K063468 · Medisurg , Ltd. · Apr 2007
MC6A
K050735 · Macan Engineering Co. · May 2005
X O ODONTOSURGE 4
K023672 · Xo Care A/S · Apr 2003
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · Diagnostic Data, Inc. · Feb 2002
K052622 · MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
Download PDF FDA Summary Macan Engineering Co.