510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K150423Substantially Equivalent

Expazen

Produits Dentaires Pierre Rolland (Acteon Group), Merignac, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K150423 is the FDA 510(k) clearance record for EXPAZEN, cleared for Produits Dentaires Pierre Rolland (Acteon Group) on under FDA product code MVL (Cord, Retraction). FDA records list one 510(k) clearance for Produits Dentaires Pierre Rolland (Acteon Group). As of , FDA records show no recalls naming K150423.

Clearance record

Decision date
Received
(139 days to decision)
Product code
MVL Cord, Retraction
Device class
Unclassified
Review panel
Unknown
Applicant
Produits Dentaires Pierre Rolland (Acteon Group) 17 Ave. Gustave Eiffel, Merignac, FR
510(k) summary
Statement
Third party review
No

Clearances, product code MVL

Trailing 12 months
2 clearances under product code MVL in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260