Cleared Traditional

K181953 - SDS1.2 dental implant

K181953 is the FDA 510(k) clearance for SDS1.2 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 485-day FDA review.

K181953 · Sds Swiss Dental Solutions AG · Dental device
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Nov 2019
Decision
485d
Days
Class 2
Risk

K181953 is an FDA 510(k) clearance for the SDS1.2 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 November 20, 2019 after a review of 485 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 Sds Swiss Dental Solutions AG devices

Submission Details

510(k) Number K181953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date November 20, 2019
Days to Decision 485 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
358d slower than avg
Panel avg: 127d · This submission: 485d
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
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