Cleared Special

K053242 - PITT-EASY DENTAL IMPLANT SYSTEM

K053242 is an FDA 510(k) clearance for PITT-EASY DENTAL IMPLANT SYSTEM, manufactured by Innova Life Sciences Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 49-day FDA review.

K053242 · Innova Life Sciences Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
49d
Days
Class 2
Risk

K053242 is an FDA 510(k) clearance for the PITT-EASY DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Innova Life Sciences Corp. (Washington, US). The FDA issued a Cleared decision on January 6, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K053242

510(k) Number K053242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2005
Decision Date January 06, 2006
Days to Decision 49 days
Submission Type Special
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
79d faster than avg
Panel avg: 128d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053242.
ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052951 · Innova Life Sciences Corp. · Jan 2006
ZIMMER DENTAL ONE-PIECE IMPLANT
K052997 · Zimmer Dental, Inc. · Jan 2006
EXFEEL IMPLANT SYSTEM
K052369 · Megagen Co., Ltd. · Jan 2006
HDC SPIDER SCREW
K052471 · Hdc S.R.L. · Dec 2005
ALMITECH INC. DENTAL IMPLANT SYSTEM
K052733 · Almitech, Inc. · Dec 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052490 · Northern Implants, LLC · Dec 2005
K053242 · PITT-EASY DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Innova Life Sciences …