Cleared Traditional

K011038 - TAPER-LOCK DENTAL IMPLANT SYSTEM

K011038 is an FDA 510(k) clearance for TAPER-LOCK DENTAL IMPLANT SYSTEM, manufactured by Sulzer Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K011038 · Sulzer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
40d
Days
Class 2
Risk

K011038 is an FDA 510(k) clearance for the TAPER-LOCK DENTAL IMPLANT SYSTEM. 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 May 15, 2001 after a review of 40 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 Sulzer Dental, Inc. devices

FDA 510(k) Submission Details - K011038

510(k) Number K011038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date May 15, 2001
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
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 1126
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K011038.
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K991822 · Dr. Ihde Dental AG Switzerland · Aug 2001
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K010458 · BioHorizons Implant Systems, Inc. · May 2001
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K003271 · Institut Straumann AG · Mar 2001