EXPAZEN
Cord, Retraction
PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP)
The following data is part of a premarket notification filed by Produits Dentaires Pierre Rolland (acteon Group) with the FDA for Expazen.
Pre-market Notification Details
| Device ID | K150423 |
| 510k Number | K150423 |
| Device Name: | EXPAZEN |
| Classification | Cord, Retraction |
| Applicant | PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) 17 AVENUE GUSTAVE EIFFEL ZI DU PHARE Merignac, FR 33708 |
| Contact | Genevieve De Villedon |
| Correspondent | Rick Rosati ACTEON, INC. 124 GAITHER DR., SUITE 140 Mount Laurel, NJ 08054 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-07-08 |
Trademark Results [EXPAZEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXPAZEN 79155904 not registered Dead/Abandoned |
PRODUITS DENTAIRES PIERRE ROLLAND 2014-08-18 |
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