Cleared Traditional

K770941 - APPLIC SYSTEM ACTIVATOR

K770941 is the FDA 510(k) clearance for APPLIC SYSTEM ACTIVATOR by Espe GmbH (Us). It is a Class 1 Dental device (product code EID) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770941 · Espe GmbH (Us) · Dental device
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Jun 1977
Decision
10d
Days
Class 1
Risk

K770941 is an FDA 510(k) clearance for the APPLIC SYSTEM ACTIVATOR, ESPE. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on June 2, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Espe GmbH (Us) devices

Submission Details

510(k) Number K770941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1977
Decision Date June 02, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EID Syringe, Restorative And Impression Material
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.