Cleared Traditional

K990979 - STECO-TITANMAGNETICS

K990979 is an FDA 510(k) clearance for STECO-TITANMAGNETICS, manufactured by Steco-System-Technik GmbH & Cokg. The device is a Class 1 Dental device with product code EGG cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K990979

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 127d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

EGG Device Classification - Class 1, General Controls

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.

Regulatory Peers - EGG Attachment, Precision, All

All 8
Devices cleared under the same product code (EGG) and FDA review panel - the closest regulatory comparables to K990979.
COUPLING DEVICE FOR DENTAL PROSTHESIS
K950259 · Dr. Joseph E. Grasso, D.D.S. · Dec 1996
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · Metalor Dental USA Corp. · Aug 1991
CONICAST, INTRACAST, OMECAST
K912567 · Metalor Dental USA Corp. · Jul 1991
INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
K901928 · Interpore Intl. · Jul 1990
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · Interpore Intl. · Mar 1987
DYNA SYSTEM
K855167 · Parker Laboratories, Inc. · Mar 1986