FDA 510(k) Applications Submitted by PARKELL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K101044 |
04/14/2010 |
RETRIEVE IMPLANT CEMENT |
PARKELL, INC. |
| K022097 |
06/27/2002 |
THERMIQUE |
PARKELL, INC. |
| K002195 |
07/20/2000 |
FORAMATRON V, MODEL D680 |
PARKELL, INC. |
| K063003 |
10/02/2006 |
AURORA |
PARKELL, INC. |
| K113839 |
12/28/2011 |
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE |
PARKELL, INC. |
| K073698 |
12/31/2007 |
SECURE |
PARKELL, INC. |
| K080549 |
02/27/2008 |
DURAFINISH ALL-CURE, MODEL S296 |
PARKELL, INC. |
| K190930 |
04/10/2019 |
SmarTemp X1 |
Parkell, Inc. |
| K191103 |
04/25/2019 |
Parkell Desensitizer Gel |
Parkell, Inc. |
| K151518 |
06/05/2015 |
BRUSH&BOND PLUS |
Parkell, Inc. |
| K172176 |
07/19/2017 |
Parkell Universal Adhesive |
Parkell, Inc. |
| K182296 |
08/24/2018 |
HyperFil-LV |
Parkell, Inc. |
| K142848 |
09/30/2014 |
EAZY PRIMER |
Parkell, Inc. |
| K982050 |
06/11/1998 |
MODEL MS-2 HANDPIECE |
PARKELL, INC. |
| K020239 |
01/23/2002 |
TOUCH&BOND-PLUS |
PARKELL, INC. |
| K960464 |
01/30/1996 |
C & B METABOND (MODIFICATION) |
PARKELL, INC. |
| K990381 |
02/08/1999 |
TOTALBOND |
PARKELL, INC. |
| K010475 |
02/20/2001 |
D/C CORE MATERIAL |
PARKELL, INC. |
| K960879 |
03/04/1996 |
AMALGAMIBOND PLUS |
PARKELL, INC. |
| K040599 |
03/08/2004 |
PARKELL RESIN GLAZE |
PARKELL, INC. |
| K060946 |
04/06/2006 |
CZ-S2000 |
PARKELL, INC. |
| K991270 |
04/13/1999 |
SMARTEMP |
PARKELL, INC. |
| K031212 |
04/17/2003 |
TEMPORARY RESIN CEMENT |
PARKELL, INC. |
| K972421 |
06/27/1997 |
EASY BOND |
PARKELL, INC. |
| K032179 |
07/14/2003 |
COMP. E |
PARKELL, INC. |
| K962741 |
07/15/1996 |
TRI-PHASIX CHROMATIC ALGINATE |
PARKELL, INC. |
| K012360 |
07/25/2001 |
LC TEMPORARY FILLING |
PARKELL, INC. |
| K973200 |
08/26/1997 |
CARIES STAIN |
PARKELL, INC. |
| K062518 |
08/28/2006 |
CELERITY |
PARKELL, INC. |
| K973679 |
09/26/1997 |
AEROETCHER |
PARKELL, INC. |
| K983413 |
09/28/1998 |
MODEL MS-1 HANDPIECE |
PARKELL, INC. |
| K973976 |
10/20/1997 |
EPIC-FLO |
PARKELL, INC. |
| K964867 |
12/05/1996 |
HYBRID RESIN COMPOSITE |
PARKELL, INC. |
| K053516 |
12/16/2005 |
MUCOHARD |
PARKELL, INC. |
| K994302 |
12/21/1999 |
RESIN TOOTH BONDING AGENT |
PARKELL, INC. |
| K974865 |
12/29/1997 |
CSR |
PARKELL, INC. |
| K132115 |
07/09/2013 |
ABSOLUTE DENTIN 2 |
PARKELL, INC. |
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