Cleared Traditional

K914764 - STERN ERA IMPLANT ABUTMENT

K914764 is an FDA 510(k) clearance for STERN ERA IMPLANT ABUTMENT, manufactured by Sterngold/Implamed. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K914764 · Sterngold/Implamed · Dental device
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Jan 1992
Decision
87d
Days
Class 2
Risk

K914764 is an FDA 510(k) clearance for the STERN ERA IMPLANT ABUTMENT. 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 17, 1992 after a review of 87 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. 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.

View all Sterngold/Implamed devices

FDA 510(k) Submission Details - K914764

510(k) Number K914764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date January 17, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
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 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K914764.
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