Cleared Traditional

K012055 - 3.25MM SPLINE TWIST IMPLANT

K012055 is an FDA 510(k) clearance for 3.25MM SPLINE TWIST IMPLANT, 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 66-day FDA review.

K012055 · Sulzer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
66d
Days
Class 2
Risk

K012055 is an FDA 510(k) clearance for the 3.25MM SPLINE TWIST IMPLANT. 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 September 6, 2001 after a review of 66 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 - K012055

510(k) Number K012055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date September 06, 2001
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K012055.
OSSEOTITE DENTAL IMPLANTS
K013570 · Implant Innovations, Inc. · Dec 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · Quantum Bioengineering, Ltd. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
K991822 · Dr. Ihde Dental AG Switzerland · Aug 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001