Cleared Traditional

K053353 - RESCUE IMPLANT SYSTEM

K053353 is an FDA 510(k) clearance for RESCUE IMPLANT SYSTEM, manufactured by Megagen Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K053353 · Megagen Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
138d
Days
Class 2
Risk

K053353 is an FDA 510(k) clearance for the RESCUE IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 19, 2006 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Megagen Co., Ltd. devices

FDA 510(k) Submission Details - K053353

510(k) Number K053353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2005
Decision Date April 19, 2006
Days to Decision 138 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
11d slower than avg
Panel avg: 127d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 892
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053353.
SPEEDY ORTHODONTIC SCREW
K060500 · Dentium Co., Ltd. · Jun 2006
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MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
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OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
K051798 · Osteomed LP · Apr 2006
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
K053384 · Astra Tech, Inc. · Mar 2006
SLACTIVE IMPLANTS
K053088 · Institut Straumann AG · Feb 2006