Cleared Traditional

K160398 - MRI Compatibility for Existing Zimmer D...

K160398 is the FDA 510(k) clearance for MRI Compatibility for Existing Zimmer D... by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 460-day FDA review.

K160398 · Zimmer Dental, Inc. · Dental device
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May 2017
Decision
460d
Days
Class 2
Risk

K160398 is an FDA 510(k) clearance for the MRI Compatibility for Existing Zimmer Dental Implant Systems. 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 May 17, 2017 after a review of 460 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Zimmer Dental, Inc. devices

Submission Details

510(k) Number K160398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2016
Decision Date May 17, 2017
Days to Decision 460 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 127d · This submission: 460d
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
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