Cleared Traditional

ZIONOMER CEMENT (K852196) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852196 · Den-Mat Corp. · Dental device
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Jun 1985
Decision
31d
Days
Class 2
Risk

K852196 is an FDA 510(k) clearance for the ZIONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Den-Mat Corp. (Santa Maria, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 31 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 Den-Mat Corp. devices

Submission Details

510(k) Number K852196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date June 20, 1985
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K852196.
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987
MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES
K864725 · Dentsply Intl. · Jan 1987
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986
CHEMFIL
K812858 · Dentsply Intl. · Dec 1981
CEMENT, CERAMCO
K790127 · Johnson & Johnson Professionals, Inc. · Feb 1979