Cleared Traditional

NIMETIC POLISHING PASTE (K771852) - FDA 510(k) Clearance

Class I Dental device.

K771852 · Espe GmbH (Us) · Dental device
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Nov 1977
Decision
34d
Days
Class 1
Risk

K771852 is an FDA 510(k) clearance for the NIMETIC POLISHING PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Espe GmbH (Us) (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 K771852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1977
Decision Date November 02, 1977
Days to Decision 34 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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.