Cleared Traditional

K891064 - ESPE CAPMIX

K891064 is an FDA 510(k) clearance for ESPE CAPMIX, manufactured by Espe GmbH (Us). The device is a Class 1 Dental device with product code EFD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K891064 · Espe GmbH (Us) · Dental device
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May 1989
Decision
90d
Days
Class 1
Risk

K891064 is an FDA 510(k) clearance for the ESPE CAPMIX. Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on May 30, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3100 - 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 Espe GmbH (Us) devices

FDA 510(k) Submission Details - K891064

510(k) Number K891064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date May 30, 1989
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFD Device Classification - Class 1, General Controls

Product Code EFD Amalgamator, Dental, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3100
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.