Cleared Traditional

K913417 - ETEX DENTAL IMPLANT SYSTEM

K913417 is an FDA 510(k) clearance for ETEX DENTAL IMPLANT SYSTEM, manufactured by Etex Co.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K913417 · Etex Co. · Dental device
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Feb 1992
Decision
203d
Days
Class 2
Risk

K913417 is an FDA 510(k) clearance for the ETEX DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Etex Co. (Cambridge, US). The FDA issued a Cleared decision on February 19, 1992 after a review of 203 days - an extended review 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: 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 Etex Co. devices

FDA 510(k) Submission Details - K913417

510(k) Number K913417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1991
Decision Date February 19, 1992
Days to Decision 203 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
76d slower than avg
Panel avg: 127d · This submission: 203d
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 1323
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K913417.
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
O BUTMENT HB
K921933 · "O" Co., Inc. · Jul 1992
IMZ SURGICAL INSTRUMENT TRAY
K921246 · Interpore Intl. · Jun 1992
OBUTMENT HB
K903999 · "O" Co., Inc. · Feb 1992
PRE-ANGLED ABUTMENTS
K912059 · Core-Vent Corp. · Feb 1992
BUR,DENTAL (76EJL)
K915597 · Calcitek, Inc. · Feb 1992