Cleared Special

K010073 - SPLINE DENTAL IMPLANT SYSTEM

K010073 is an FDA 510(k) clearance for SPLINE DENTAL IMPLANT SYSTEM, manufactured by Sulzer Calcitek, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 10-day FDA review.

K010073 · Sulzer Calcitek, Inc. · Dental device
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Jan 2001
Decision
10d
Days
Class 2
Risk

K010073 is an FDA 510(k) clearance for the SPLINE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sulzer Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 10 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sulzer Calcitek, Inc. devices

FDA 510(k) Submission Details - K010073

510(k) Number K010073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2001
Decision Date January 19, 2001
Days to Decision 10 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010073.
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K003271 · Institut Straumann AG · Mar 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · Ace Surgical Supply Co., Inc. · Feb 2001
OCO DENTAL IMPLANT
K010142 · "O" Co., Inc. · Feb 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K002513 · Astra Tech, Inc. · Jan 2001
ADVENT IMPLANT SYSTEM
K002614 · Core-Vent Corp. · Dec 2000