Cleared Traditional

K911735 - ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT

K911735 is an FDA 510(k) clearance for ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT, manufactured by Artech Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K911735 · Artech Corp. · Dental device
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Mar 1992
Decision
323d
Days
Class 2
Risk

K911735 is an FDA 510(k) clearance for the ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Artech Corp. (Chantilly, US). The FDA issued a Cleared decision on March 5, 1992 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Artech Corp. devices

FDA 510(k) Submission Details - K911735

510(k) Number K911735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date March 05, 1992
Days to Decision 323 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 127d · This submission: 323d
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 K911735.
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K915733 · Steri-Oss, Inc. · Jul 1992
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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