Company ยท US
Parkell, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2025. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 16 |
| EMA | Cement, Dental | 8 |
| EBF | Material, Tooth Shade, Resin | 6 |
| ELC | Scaler, Ultrasonic | 4 |
| EAT | Tester, Pulp | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 |
| ELW | Material, Impression | 3 |
| EBD | Coating, Filling Material, Resin | 2 |
| LQY | Locator, Root Apex | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 |
| KIF | Resin, Root Canal Filling | 1 |
| KOJ | Airbrush | 1 |
| LFC | Device, Caries Detection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2025 | K243254 | Parkell Pit and Fissure Sealant Parkell, Inc. | EBC |
| Jan 20, 2022 | K210259 | Parkell Self-Adhesive Cement Parkell, Inc. | EMA |
| Nov 22, 2019 | K191103 | Parkell Desensitizer Gel Parkell, Inc. | EJK |
| Sep 5, 2019 | K190930 | SmarTemp X1 Parkell, Inc. | EBG |
| Dec 14, 2018 | K182296 | HyperFil-LV Parkell, Inc. | EBF |
| Nov 21, 2017 | K172176 | Parkell Universal Adhesive Parkell, Inc. | KLE |
| Sep 18, 2015 | K151518 | BRUSH&BOND PLUS Parkell, Inc. | KLE |
| Feb 24, 2015 | K142848 | EAZY PRIMER Parkell, Inc. | KLE |
| Jun 25, 2014 | K132115 | ABSOLUTE DENTIN 2 Parkell, Inc. | EBF |
| Apr 12, 2012 | K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE Parkell, Inc. | MVL |
| Jun 10, 2010 | K101044 | RETRIEVE IMPLANT CEMENT Parkell, Inc. | EMA |
| May 13, 2008 | K080549 | DURAFINISH ALL-CURE, MODEL S296 Parkell, Inc. | EBD |
| Mar 19, 2008 | K073698 | SECURE Parkell, Inc. | EMA |
| Dec 4, 2006 | K062518 | CELERITY Parkell, Inc. | EBF |
| Nov 28, 2006 | K063003 | AURORA Parkell, Inc. | EBZ |
| Jun 15, 2006 | K060946 | CZ-S2000 Parkell, Inc. | KIF |
| Jan 26, 2006 | K053516 | MUCOHARD Parkell, Inc. | EBI |
| Apr 9, 2004 | K040599 | PARKELL RESIN GLAZE Parkell, Inc. | EBD |
| Sep 9, 2003 | K032179 | COMP. E Parkell, Inc. | KLE |
| Jul 11, 2003 | K031212 | TEMPORARY RESIN CEMENT Parkell, Inc. | EMA |
| Sep 6, 2002 | K022097 | THERMIQUE Parkell, Inc. | EAT |
| Mar 20, 2002 | K020239 | TOUCH&BOND-PLUS Parkell, Inc. | KLE |
| Sep 6, 2001 | K012360 | LC TEMPORARY FILLING Parkell, Inc. | EBG |
| May 7, 2001 | K010475 | D/C CORE MATERIAL Parkell, Inc. | EBF |
| Aug 30, 2000 | K002195 | FORAMATRON V, MODEL D680 Parkell, Inc. | LQY |
| Feb 7, 2000 | K994302 | RESIN TOOTH BONDING AGENT Parkell, Inc. | KLE |
| May 21, 1999 | K991270 | SMARTEMP Parkell, Inc. | EBG |
| May 17, 1999 | K990381 | TOTALBOND Parkell, Inc. | EMA |
| Dec 21, 1998 | K983413 | MODEL MS-1 HANDPIECE Parkell, Inc. | EKX |
| Sep 2, 1998 | K982050 | MODEL MS-2 HANDPIECE Parkell, Inc. | EFB |
| Mar 16, 1998 | K974865 | CSR Parkell, Inc. | EBI |
| Mar 10, 1998 | K973679 | AEROETCHER Parkell, Inc. | KOJ |
| Dec 4, 1997 | K973976 | EPIC-FLO Parkell, Inc. | EBF |
| Nov 6, 1997 | K973200 | CARIES STAIN Parkell, Inc. | LFC |
| Aug 29, 1997 | K972421 | EASY BOND Parkell, Inc. | KLE |
| Apr 11, 1997 | K964867 | HYBRID RESIN COMPOSITE Parkell, Inc. | KLE |
| Sep 6, 1996 | K962741 | TRI-PHASIX CHROMATIC ALGINATE Parkell, Inc. | ELW |
| Mar 22, 1996 | K960879 | AMALGAMIBOND PLUS Parkell, Inc. | KLE |
| Feb 26, 1996 | K960464 | C & B METABOND (MODIFICATION) Parkell, Inc. | EMA |
| Jun 20, 1995 | K952124 | ABOND Parkell, Inc. | KLE |
| Jun 20, 1995 | K952123 | MS EMULSION Parkell, Inc. | KLE |
| Jun 9, 1995 | K950237 | DIGITEST Parkell, Inc. | EAT |
| Jun 6, 1995 | K950239 | SENSIMATIC 500SE Parkell, Inc. | EKZ |
| May 9, 1995 | K950238 | GENTAL PULSE Parkell, Inc. | EAT |
| Apr 20, 1995 | K950857 | FORAMATRON IV Parkell, Inc. | LQY |
| Apr 10, 1995 | K950905 | C&B-METABOND RADIOPAQUE POWDER Parkell, Inc. | KLE |
| Apr 4, 1995 | K950256 | TURBO 25/30 Parkell, Inc. | ELC |
| Apr 4, 1995 | K950240 | LE CLEAN MACHINE Parkell, Inc. | ELC |
| Jul 6, 1994 | K942017 | V-PRIMER Parkell, Inc. | KLE |
| Oct 20, 1993 | K933547 | INTRA-ORAL IRRIGATOR Parkell, Inc. | ELC |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||