Cleared Traditional

K150601 - Zeramic Adhesive Resin Cement (FDA 510(k) Clearance)

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

K150601 · Premier Dental Company Products · Dental device
Jul 2015
Decision
134d
Days
Class 2
Risk

K150601 is an FDA 510(k) clearance for the Zeramic Adhesive Resin Cement. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Premier Dental Company Products (Plymouth Meeting, US). The FDA issued a Cleared decision on July 22, 2015 after a review of 134 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.

Submission Details

510(k) Number K150601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date July 22, 2015
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 158d · This submission: 134d
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 18
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K150601.
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · Voco GmbH · Mar 2026
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GlasIonomer FX-LC
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ZIRCONOMER P
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EQUIA LC ONE
K250953 · GC America, Inc. · Sep 2025