Cleared Traditional

K994027 - ACTIVATOR PASTE

K994027 is the FDA 510(k) clearance for ACTIVATOR PASTE by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K994027 · Harry J. Bosworth Co. · Dental device
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Apr 2000
Decision
139d
Days
Class 2
Risk

K994027 is an FDA 510(k) clearance for the ACTIVATOR PASTE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 139 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K994027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date April 13, 2000
Days to Decision 139 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
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K994027.
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
FLEXTIME
K000629 · Heraeus Kulzer, Inc. · Apr 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · GC America, Inc. · Jan 2000
XANTOPREN COMFORT
K991425 · Heraeus Kulzer, Inc. · Jun 1999