Cleared Traditional

K122974 - TRYOUT-VPS HOLDING PASTE

K122974 is the FDA 510(k) clearance for TRYOUT-VPS HOLDING PASTE by Crown Delta Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K122974 · Crown Delta Corp. · Dental device
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May 2013
Decision
233d
Days
Class 2
Risk

K122974 is an FDA 510(k) clearance for the TRYOUT-VPS HOLDING PASTE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Crown Delta Corp. (Yorktown Heights, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 233 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 Crown Delta Corp. devices

Submission Details

510(k) Number K122974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date May 17, 2013
Days to Decision 233 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
106d slower than avg
Panel avg: 127d · This submission: 233d
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.