Cleared Traditional

K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems

K190662 is an FDA 510(k) clearance for MRI Compatibility for Existing Strauman..., manufactured by Straumann USA, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K190662 · Straumann USA, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K190662

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
Combination Product No
PCCP Authorized No
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.

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 1192
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K190662.
PRAMA White Implant Systems
K180365 · Sweden & Martina S.P.A. · Jul 2019
Surgikor Dental Implant System
K182615 · Surgikor, LLC · Jul 2019
AlphaDent Implants Dental Implants System
K180968 · Alphadent Implants, Ltd. · Jul 2019
Conical Plus Implant System
K181157 · Osseofuse International, Inc. · May 2019
ET IV SA Dental Implants
K183242 · Hiossen, Inc. · May 2019
Reflect Implant System
K180924 · Ids - Integrated Dental Systems · Mar 2019