Cleared Traditional

K914073 - F21 DENTAL CEMENT

K914073 is the FDA 510(k) clearance for F21 DENTAL CEMENT by Voco GmbH. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K914073 · Voco GmbH · Dental device
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Oct 1991
Decision
40d
Days
Class 2
Risk

K914073 is an FDA 510(k) clearance for the F21(R) DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 40 days - a notably fast clearance cycle.

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: 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 Voco GmbH devices

Submission Details

510(k) Number K914073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date October 21, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K914073.
IONOFIL/LONOFIL MOLAR
K915619 · Voco GmbH · Feb 1992
MERON DENTAL CEMENT
K914612 · Voco GmbH · Feb 1992
PHOTAC-BOND APLICAP, MODIFICATION
K915005 · Espe GmbH (Us) · Jan 1992
VLC GLASS IONOMER
K913836 · Dentsply Intl. · Oct 1991
IONOBOND
K912497 · Voco GmbH · Jul 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991