Cleared Traditional

K030727 - POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT

K030727 is an FDA 510(k) clearance for POTASSIUM NITRATE/ZINC OXIDE EUGENOL TE..., manufactured by Healex Products, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030727 · Healex Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
90d
Days
Class 2
Risk

K030727 is an FDA 510(k) clearance for the POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Healex Products, Inc. (Providence, US). The FDA issued a Cleared decision on June 5, 2003 after a review of 90 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 Healex Products, Inc. devices

FDA 510(k) Submission Details - K030727

510(k) Number K030727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2003
Decision Date June 05, 2003
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 396
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K030727.
COLTOSOL F
K031752 · Coltene/Whaledent, Inc. · Aug 2003
GLASIONOMER FX-II
K031467 · Shofu Dental Corp. · Jul 2003
TEMPORARY RESIN CEMENT
K031212 · Parkell, Inc. · Jul 2003
RIVA-SELF CURE
K030516 · Southern Dental Industries, Inc. · Apr 2003
AGC CEM
K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
VITIQUE SYSTEM
K023649 · Dmg USA, Inc. · Jan 2003