Cleared Traditional

K994027 - ACTIVATOR PASTE

K994027 is an FDA 510(k) clearance for ACTIVATOR PASTE, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K994027

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
Combination Product No
PCCP Authorized No
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.

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 288
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