Cleared Traditional

K093164 - 3.25 SPLINE TWIST IMPLANT, HA COATED

K093164 is an FDA 510(k) clearance for 3.25 SPLINE TWIST IMPLANT, manufactured by Zimmer Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K093164 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
70d
Days
Class 2
Risk

K093164 is an FDA 510(k) clearance for the 3.25 SPLINE TWIST IMPLANT, HA COATED. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 70 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 Zimmer Dental, Inc. devices

FDA 510(k) Submission Details - K093164

510(k) Number K093164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2009
Decision Date December 15, 2009
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 1175
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K093164.
HG II SHORT FIXTURE SYSTEM
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HG III FIXTURE SYSTEM
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K092594 · Ace Surgical Supply Co., Inc. · Sep 2009
SINUS QUICK EB SYSTEM
K090377 · Neobiotech Co., Ltd. · Aug 2009