Cleared Traditional

K150704 - PANAVIA V5: Standard Kit (Universal (A2))

K150704 is the FDA 510(k) clearance for PANAVIA V5: Standard Kit (Universal (A2)) by Kuraray Noritake Dental, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K150704 · Kuraray Noritake Dental, Inc. · Dental device
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Aug 2015
Decision
156d
Days
Class 2
Risk

K150704 is an FDA 510(k) clearance for the PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory.... Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (Chiyoda Ku, JP). The FDA issued a Cleared decision on August 21, 2015 after a review of 156 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 Kuraray Noritake Dental, Inc. devices

Submission Details

510(k) Number K150704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2015
Decision Date August 21, 2015
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
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.

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