Cleared Traditional

K914318 - GLASS IONOMER CEMENT

K914318 is the FDA 510(k) clearance for GLASS IONOMER CEMENT by Confi-Dental Products Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K914318 · Confi-Dental Products Co. · Dental device
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Mar 1992
Decision
176d
Days
Class 2
Risk

K914318 is an FDA 510(k) clearance for the GLASS IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 176 days - an extended review 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: 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 Confi-Dental Products Co. devices

Submission Details

510(k) Number K914318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1991
Decision Date March 20, 1992
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 127d · This submission: 176d
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.