Cleared Traditional

K150423 - EXPAZEN

K150423 · Produits Dentaires Pierre Rolland (Acteon Group) · Dental device
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Jul 2015
Decision
139d
Days
-
Risk

K150423 is an FDA 510(k) clearance for the EXPAZEN. Classified as Cord, Retraction (product code MVL).

Submitted by Produits Dentaires Pierre Rolland (Acteon Group) (Merignac, FR). The FDA issued a Cleared decision on July 8, 2015 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Produits Dentaires Pierre Rolland (Acteon Group) devices

FDA 510(k) Submission Details - K150423

510(k) Number K150423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2015
Decision Date July 08, 2015
Days to Decision 139 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
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 28
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