Cleared Traditional

K991450 - ETCHING GEL

K991450 is an FDA 510(k) clearance for ETCHING GEL, manufactured by Silicon-Und Composite Spezialitaten GmbH. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K991450 · Silicon-Und Composite Spezialitaten GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
74d
Days
Class 2
Risk

K991450 is an FDA 510(k) clearance for the ETCHING GEL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Silicon-Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on July 9, 1999 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Silicon-Und Composite Spezialitaten GmbH devices

FDA 510(k) Submission Details - K991450

510(k) Number K991450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date July 09, 1999
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 745
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K991450.
POST CEMENT HI-X
K992248 · Bisco, Inc. · Aug 1999
PRODIGY 4 TRANSLUCENT SHADES
K992118 · Sybron Dental Specialties, Inc. · Aug 1999
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
SELF CURE COMPOSITE
K991488 · Harry J. Bosworth Co. · Jun 1999
FLC COMPOSITE
K991491 · Harry J. Bosworth Co. · Jun 1999
LC MICROFILL
K991442 · S & C Polymer GmbH · Jun 1999