The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Optiflow Ii Flowable Composite, Lc.
Device ID | K130672 |
510k Number | K130672 |
Device Name: | OPTIFLOW II FLOWABLE COMPOSITE, LC |
Classification | Material, Tooth Shade, Resin |
Applicant | PAC-DENT INTERNATIONAL, INC. 21038 Commerce Pointe Dr. Walnut, CA 91789 |
Contact | Wenying Zhu |
Correspondent | Wenying Zhu PAC-DENT INTERNATIONAL, INC. 21038 Commerce Pointe Dr. Walnut, CA 91789 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-12 |
Decision Date | 2013-08-13 |
Summary: | summary |