Cleared Traditional

HEX-LOCK TEMPORARY ABUTMENT (K014050) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014050 · Sulzer Dental, Inc. · Dental device
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Nov 2002
Decision
338d
Days
Class 2
Risk

K014050 is an FDA 510(k) clearance for the HEX-LOCK TEMPORARY ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sulzer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 13, 2002 after a review of 338 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 Sulzer Dental, Inc. devices

Submission Details

510(k) Number K014050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date November 13, 2002
Days to Decision 338 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 127d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 303
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