FDA 510(k) Applications Submitted by WENYING ZHU
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160577 |
03/01/2016 |
PacEndo Chlorhexidine |
PAC-DENT INTERNATIONAL, INC. |
| K130672 |
03/12/2013 |
OPTIFLOW II FLOWABLE COMPOSITE, LC |
PAC-DENT INTERNATIONAL, INC. |
| K151123 |
04/28/2015 |
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film |
Pac-Dent International, Inc. |
| K151150 |
04/30/2015 |
Elements |
PAC-DENT INTERNATIONAL, INC. |
| K141422 |
05/30/2014 |
PROFLUORO FLUORIDE VARNISH |
PAC-DENT INTERNATIONAL, INC. |
| K141717 |
06/25/2014 |
PACSEAL PIT & FISSURE SEALANT |
PAC-DENT INTERNATIONAL, INC. |
| K151852 |
07/07/2015 |
PacEndo Sodium Hyprochlorite |
PAC-DENT INTERNATIONAL, INC. |
| K153528 |
12/09/2015 |
PacEndo EDTA |
PAC-DENT INTERNATIONAL, INC. |
| K181135 |
04/30/2018 |
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
| K183048 |
11/02/2018 |
Quantisal II Oral Fluid Collection Device |
Immunalysis Corporation |
| K203489 |
11/27/2020 |
SEFRIA PCP Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
| K203564 |
12/07/2020 |
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
| K203647 |
12/14/2020 |
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
| K200801 |
03/27/2020 |
Quantisal Oral Fluid Collection Device |
Immunalysis Corporation |
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