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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 128d · 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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053353.
ABSOANCHOR MICROIMPLANT
K060126 · Dentos, Inc. · May 2006
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K060957 · Blue Sky Bio, LLC · May 2006
SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
K060376 · Simpler Implant, Inc. · Apr 2006
INTERMEZZO PLUS FIXTURE
K053354 · Megagen Co., Ltd. · Apr 2006
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
K051798 · Osteomed LP · Apr 2006
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K053478 · Northern Implants, LLC · Apr 2006
K053353 · RESCUE IMPLANT SYSTEM
Download PDF FDA Summary Megagen Co., Ltd.