This page includes the latest FDA filings for Parkell Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Parkell Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 2411797 |
| FEI Number | 2411797 |
| Name | PARKELL, INC. |
| Owner & Operator | Parkell Inc |
| Contact Address | 300 Executive Drive Edgewood NY 11717 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US |
| Establishment Type |
|
| Registration Number | 3011175550 |
| FEI Number | 3011175550 |
| Name | DIRECTA INC |
| Owner & Operator | Parkell Inc |
| Contact Address | 300 Executive Drive Edgewood NY 11717 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 64 Barnabas Rd Unit3 Newtown, CT 06470 US |
Device Company | Device | Date |
|---|---|---|
| PARKELL, INC. | Dryz™ S180 | 2024-04-03 |
| PARKELL, INC. | HyperFIL® S235 | 2024-03-11 |
| PARKELL, INC. | HyperFIL® S234 | 2024-03-11 |
| PARKELL, INC. | 20/20™ S475 | 2024-01-29 |
| PARKELL, INC. | Cinch™ S470 | 2024-01-26 |
| PARKELL, INC. | Cinch™ S469 | 2024-01-26 |
| PARKELL, INC. | Blu-Mousse® S448S | 2024-01-25 |
| PARKELL, INC. | Blu-Mousse® S440S | 2024-01-25 |
| PARKELL, INC. | Blu-Mousse® S437S | 2024-01-25 |
| PARKELL, INC. | Mach-2® S433S | 2024-01-25 |
| PARKELL, INC. | TurboSENSOR™ D560-110DE | 2024-01-24 |
| PARKELL, INC. | Aurora™ D541 | 2023-12-22 |
| PARKELL, INC. | C&B METABOND® S378 | 2023-12-22 |
| PARKELL, INC. | AccuFilm® S015 | 2023-12-21 |
| PARKELL, INC. | AccuFilm® S014 | 2023-12-21 |
| PARKELL, INC. | AccuFilm® S053 | 2023-12-21 |
| PARKELL, INC. | AccuFilm® S021 | 2023-12-21 |
| PARKELL, INC. | AccuFilm® S018 | 2023-12-21 |
| PARKELL, INC. | AccuFilm® S017 | 2023-12-21 |
| PARKELL, INC. | Parkell® S377 | 2023-12-04 |
| PARKELL, INC. | MucoSoft™ S495 | 2023-12-04 |
| PARKELL, INC. | GentleCLEAN™ DSG30GCT | 2023-12-04 |
| PARKELL, INC. | Parkell® D558 | 2023-12-04 |
| PARKELL, INC. | Parkell® D557 | 2023-12-04 |
| PARKELL, INC. | Dryz™ S184SPJ | 2023-12-04 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-08 | 2023-11-09 |
| PARKELL, INC. | DuraTip® DURA30-US | 2023-10-30 |
| PARKELL, INC. | DuraTip® DURA30-PS | 2023-10-30 |
| PARKELL, INC. | Parkell® D323 | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D729 | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660-LOANER | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660-P | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660-O | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660-N | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660-B | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D660 | 2023-10-30 |
| PARKELL, INC. | Parkell® D723 | 2023-10-30 |
| PARKELL, INC. | TurboSENSOR +™ D722 | 2023-10-30 |
| PARKELL, INC. | Parkell® D588 | 2023-10-30 |
| PARKELL, INC. | Epic® S366UD | 2023-08-24 |
| PARKELL, INC. | Epic® S363UD | 2023-08-24 |
| PARKELL, INC. | Epic® S362UD | 2023-08-24 |
| PARKELL, INC. | Epic® S361UD | 2023-08-24 |
| PARKELL, INC. | Epic® S360UD | 2023-08-24 |
| PARKELL, INC. | Epic® S360 | 2023-08-24 |
| PARKELL, INC. | Epic® S357UD | 2023-08-24 |
| PARKELL, INC. | Epic® S356UD | 2023-08-24 |
| PARKELL, INC. | Brush&Bond® S287 | 2023-08-24 |
| PARKELL, INC. | Brush&Bond® S286 | 2023-08-24 |
| PARKELL, INC. | Simplee® 156215 | 2023-06-19 |
| PARKELL, INC. | Parkell® S276 | 2023-06-14 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-18 | 2023-04-13 |
| PARKELL, INC. | Blu-Mousse® S457 | 2023-04-13 |
| PARKELL, INC. | Blu-Mousse® S438 | 2023-04-13 |
| PARKELL, INC. | PerioSonic® D581 | 2023-04-13 |
| PARKELL, INC. | Sensimatic™ D700SE10CR | 2023-04-04 |
| PARKELL, INC. | Sensimatic™ D600SE110 | 2023-04-04 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-16 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-15 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-11 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-04 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-03 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-01 | 2022-12-07 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-20 | 2022-09-22 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-17 | 2022-09-22 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-09 | 2022-09-22 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-19 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-14 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-13 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-12 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-10 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-07 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-06 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-05 | 2022-07-28 |
| PARKELL, INC. | Gripper™ Soft Copper Band S702-02 | 2022-07-28 |
| PARKELL, INC. | Parkell® S379 | 2022-07-21 |
| PARKELL, INC. | Dryz™ S181 | 2022-07-21 |
| PARKELL, INC. | Parkell® D419 | 2022-07-21 |
| PARKELL, INC. | Parkell® D619GC | 2022-07-18 |
| PARKELL, INC. | Parkell® S633 | 2022-07-04 |
| PARKELL, INC. | MucoHard™ S642 | 2022-07-04 |
| PARKELL, INC. | MucoHard™ S641 | 2022-07-04 |
| PARKELL, INC. | MucoHard™ S640 | 2022-07-04 |
| PARKELL, INC. | Blu-Mousse® S439K | 2022-06-03 |
| PARKELL, INC. | Blu-Mousse® S439IOT | 2022-06-03 |
| PARKELL, INC. | Pain-Free™ S383 | 2022-06-03 |
| PARKELL, INC. | SmarTemp® S344 | 2022-06-03 |
| PARKELL, INC. | Absolute Dentin™ S335 | 2022-06-03 |
| PARKELL, INC. | Absolute Dentin™ S334 | 2022-06-03 |
| PARKELL, INC. | HyperFIL™ S329 | 2022-06-03 |
| PARKELL, INC. | HyperFIL™ S328 | 2022-06-03 |
| PARKELL, INC. | Absolute Dentin™ S308 | 2022-06-03 |
| PARKELL, INC. | Absolute Dentin™ S303 | 2022-06-03 |
| PARKELL, INC. | Absolute Dentin™ S302 | 2022-06-03 |
| PARKELL, INC. | Retrieve™ S292 | 2022-06-03 |
| PARKELL, INC. | SEcure® S275 | 2022-06-03 |
| PARKELL, INC. | Predicta™ S632 | 2022-05-09 |
| PARKELL, INC. | Predicta™ S631 | 2022-05-09 |
| PARKELL, INC. | Predicta™ S630 | 2022-05-09 |
| PARKELL, INC. | Brush&Bond® S220 | 2022-05-02 |
Parkell, Inc | Parkell Self-Adhesive Cement | 2022-01-20 |
Parkell, Inc. | Parkell Desensitizer Gel | 2019-11-22 |
Parkell, Inc. | SmarTemp X1 | 2019-09-05 |
Parkell, Inc. | HyperFil-LV | 2018-12-14 |
Parkell, Inc. | Parkell Universal Adhesive | 2017-11-21 |
PARKELL, INC. [Parkell Inc] | Smartemp | 2016-10-18 |
PARKELL, INC. [Parkell Inc] | Etch-free | 2016-10-18 |
PARKELL, INC. [Parkell Inc] | Resin post | 2016-10-18 |
Parkell, Inc. | BRUSH&BOND PLUS | 2015-09-18 |
Parkell, Inc. | EAZY PRIMER | 2015-02-24 |
PARKELL, INC. | ABSOLUTE DENTIN 2 | 2014-06-25 |
PARKELL, INC. | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | 2012-04-12 |
PARKELL, INC. | RETRIEVE IMPLANT CEMENT | 2010-06-10 |
PARKELL, INC. | DURAFINISH ALL-CURE, MODEL S296 | 2008-05-13 |
PARKELL, INC. | CZ-S2000 | 2006-06-15 |
PARKELL, INC. | MUCOHARD | 2006-01-26 |
PARKELL, INC. | PARKELL RESIN GLAZE | 2004-04-09 |
PARKELL, INC. | THERMIQUE | 2002-09-06 |
PARKELL, INC. | TOUCH&BOND-PLUS | 2002-03-20 |
PARKELL, INC. | FORAMATRON V, MODEL D680 | 2000-08-30 |
PARKELL, INC. | RESIN TOOTH BONDING AGENT | 2000-02-07 |
PARKELL, INC. | SMARTEMP | 1999-05-21 |
PARKELL, INC. | TOTALBOND | 1999-05-17 |
PARKELL, INC. | MODEL MS-1 HANDPIECE | 1998-12-21 |
PARKELL, INC. | MODEL MS-2 HANDPIECE | 1998-09-02 |
PARKELL, INC. | CSR | 1998-03-16 |
PARKELL, INC. | AEROETCHER | 1998-03-10 |
PARKELL, INC. | EPIC-FLO | 1997-12-04 |
PARKELL, INC. | CARIES STAIN | 1997-11-06 |
PARKELL, INC. | EASY BOND | 1997-08-29 |
PARKELL, INC. | HYBRID RESIN COMPOSITE | 1997-04-11 |
PARKELL, INC. | TRI-PHASIX CHROMATIC ALGINATE | 1996-09-06 |
PARKELL, INC. | AMALGAMIBOND PLUS | 1996-03-22 |
PARKELL, INC. | C & B METABOND (MODIFICATION) | 1996-02-26 |
PARKELL, INC. | ABOND | 1995-06-20 |
PARKELL, INC. | MS EMULSION | 1995-06-20 |
PARKELL, INC. | DIGITEST | 1995-06-09 |
PARKELL, INC. | SENSIMATIC 500SE | 1995-06-06 |
PARKELL, INC. | GENTAL PULSE | 1995-05-09 |
PARKELL, INC. | FORAMATRON IV | 1995-04-20 |
PARKELL, INC. | C&B-METABOND RADIOPAQUE POWDER | 1995-04-10 |
PARKELL, INC. | TURBO 25/30 | 1995-04-04 |
PARKELL, INC. | LE CLEAN MACHINE | 1995-04-04 |
PARKELL, INC. | V-PRIMER | 1994-07-06 |
PARKELL, INC. | INTRA-ORAL IRRIGATOR | 1993-10-20 |
PARKELL, INC. | ULTRASONIC TOOTH SCALER MODEL DSCIOP | 1985-07-01 |
PARKELL, INC. | SILAGUM | 1980-01-09 |
PARKELL, INC. | SAFE-T-PINS RETENTIVE PIN SYSTEM | 1976-10-21 |
| NCAGE Code | 24040 | PARKELL, INC. |
| CAGE Code | 24040 | PARKELL, INC. |
| S.A.M. Registration | 24040 [9900424] | PARKELL, INC. |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 20200909123505 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | MIXER | 4 PKG |
| 2020060320374 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | PLASTIKVARER | 6 PKG |
| 2020060320375 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | TREMIN | 3 PKG |
| 2020052623762 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | TREMIN | 3 PKG |
| 2020052623761 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | PLASTIKVARER | 6 PKG |
| 2020052054684 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | TREMIN | 3 PKG |
| 2020052054683 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | PLASTIKVARER | 6 PKG |
| 2020042226813 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | TREMIN | 2 PKG |