Cleared Traditional

STECO-TITANMAGNETICS (K990979) - FDA 510(k) Clearance

Class I Dental device.

K990979 · Steco-System-Technik GmbH & Cokg · Dental device
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Sep 1999
Decision
164d
Days
Class 1
Risk

K990979 is an FDA 510(k) clearance for the STECO-TITANMAGNETICS. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Steco-System-Technik GmbH & Cokg (Wurzburg, Bavaria, DE). The FDA issued a Cleared decision on September 3, 1999 after a review of 164 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3165 - 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 Steco-System-Technik GmbH & Cokg devices

Submission Details

510(k) Number K990979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date September 03, 1999
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGG Attachment, Precision, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.