Cleared Traditional

K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190662 · Straumann USA, LLC · Dental device
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Jun 2019
Decision
94d
Days
Class 2
Risk

K190662 is an FDA 510(k) clearance for the MRI Compatibility for Existing Straumann Dental Implant Systems. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA, LLC (Andover, US). The FDA issued a Cleared decision on June 17, 2019 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Straumann USA, LLC devices

Submission Details

510(k) Number K190662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2019
Decision Date June 17, 2019
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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 1541
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K190662.
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