Cleared Traditional

K992001 - TRAY-LINK

K992001 is an FDA 510(k) clearance for TRAY-LINK, manufactured by Silicon-Und Composite Spezialitaten GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K992001 · Silicon-Und Composite Spezialitaten GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
140d
Days
Class 2
Risk

K992001 is an FDA 510(k) clearance for the TRAY-LINK. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Silicon-Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on November 2, 1999 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Silicon-Und Composite Spezialitaten GmbH devices

FDA 510(k) Submission Details - K992001

510(k) Number K992001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date November 02, 1999
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 276
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K992001.
IMPREGUM PENTA DUOSOFT
K994193 · Espe Dental AG · Jan 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · GC America, Inc. · Jan 2000
IMPREGUM GARANT L DUOSOFT
K994190 · Espe Dental AG · Jan 2000
IMPREGUM F
K992895 · Espe Dental AG · Sep 1999
IMPREGUM PENTA
K992897 · Espe Dental AG · Sep 1999
FASTRAY LC
K991631 · Harry J. Bosworth Co. · Jul 1999