Cleared Traditional

K913348 - THE STERN ERA SYSTEM

K913348 is an FDA 510(k) clearance for THE STERN ERA SYSTEM, manufactured by Sterngold/Implamed. The device is a Class 2 Ear, Nose, Throat device with product code DZE cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K913348 · Sterngold/Implamed · Ear, Nose, Throat device
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Jan 1992
Decision
188d
Days
Class 2
Risk

K913348 is an FDA 510(k) clearance for the THE STERN ERA SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold/Implamed (Attleboro, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 188 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 872.3640 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterngold/Implamed devices

FDA 510(k) Submission Details - K913348

510(k) Number K913348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1991
Decision Date January 30, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 89d · This submission: 188d
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K913348.
HEXLOCK SCREW
K920909 · Imtec Corp. · Jan 1993
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
K905434 · Nobelpharma USA, Inc. · Aug 1992
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991
HEXLOCK
K912262 · Imtec Corp. · Dec 1991