Cleared Traditional

K042215 - RADIOPAQUE

K042215 is the FDA 510(k) clearance for RADIOPAQUE by Premier Dental Products Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K042215 · Premier Dental Products Co. · Dental device
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Sep 2004
Decision
36d
Days
Class 2
Risk

K042215 is an FDA 510(k) clearance for the RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on September 21, 2004 after a review of 36 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K042215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date September 21, 2004
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
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 184
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K042215.
GC FUJI FIL LC
K051427 · GC America, Inc. · Aug 2005
IONOFIL PLUS AC
K042669 · Voco GmbH · Oct 2004
DYRACT CEM PLUS CEMENT
K041272 · Dentsply Intl. · Oct 2004
MAXCEM
K041474 · Sybron Dental Specialties, Inc. · Jul 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004