Cleared Traditional

K190406 - SDS2.2 dental implant

K190406 is the FDA 510(k) clearance for SDS2.2 dental implant by Sds Swiss Dental Solutions AG. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K190406 · Sds Swiss Dental Solutions AG · Dental device
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Feb 2020
Decision
364d
Days
Class 2
Risk

K190406 is an FDA 510(k) clearance for the SDS2.2 dental implant. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sds Swiss Dental Solutions AG (Kreuzlingen, CH). The FDA issued a Cleared decision on February 20, 2020 after a review of 364 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sds Swiss Dental Solutions AG devices

Submission Details

510(k) Number K190406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date February 20, 2020
Days to Decision 364 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
237d slower than avg
Panel avg: 127d · This submission: 364d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K190406.
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