Cleared Traditional

K061717 - ZIMMER ONE-PIECE IMPLANT

K061717 is the FDA 510(k) clearance for ZIMMER ONE-PIECE IMPLANT by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K061717 · Zimmer Dental, Inc. · Dental device
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Sep 2006
Decision
81d
Days
Class 2
Risk

K061717 is an FDA 510(k) clearance for the ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED. 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 September 8, 2006 after a review of 81 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

Submission Details

510(k) Number K061717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date September 08, 2006
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
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 582
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061717.
P.0004 IMPLANTS
K062129 · Institut Straumann AG · Oct 2006
SUPER ORTHODONTIC SCREW
K062156 · Osstem Implant Co., Ltd. · Oct 2006
SCREW-VENT IMPLANT SYSTEM, SV
K061410 · Zimmer Dental, Inc. · Sep 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006
STRAUMANN DENTAL IMPLANTS
K061176 · Institut Straumann AG · Aug 2006