Cleared Traditional

K161630 - Provicol QM Plus

K161630 is an FDA 510(k) clearance for Provicol QM Plus, manufactured by Voco GmbH. The device is a Class 1 Dental device with product code EMB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K161630 · Voco GmbH · Dental device
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Sep 2016
Decision
94d
Days
Class 1
Risk

K161630 is an FDA 510(k) clearance for the Provicol QM Plus. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on September 15, 2016 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Voco GmbH devices

FDA 510(k) Submission Details - K161630

510(k) Number K161630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date September 15, 2016
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

EMB Device Classification - Class 1, General Controls

Product Code EMB Zinc Oxide Eugenol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3275
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.