Data / Medical devices / United States / Parkell, Inc.
Parkell, Inc.: FDA-registered device maker in Edgewood, NY, United States, 37 510(k) clearances
Parkell, Inc. is registered with the FDA (registration 2411797) in Edgewood, NY, United States. It lists 30 device types. The FDA files 37 510(k) clearances under its listings, the newest dated August 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2411797
- Address
- 300 Executive DR., Edgewood, NY, United States, 11717
- Owner or operator
- Parkell, Inc (10047694)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 18, 2016
- Registered through
- 2026
- Brand names listed
- Etch-free, Resin post, Smartemp
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2025 | K243254 | Parkell Pit and Fissure Sealant | EBC | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| January 20, 2022 | K210259 | Parkell Self-Adhesive Cement | EMA | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| November 22, 2019 | K191103 | Parkell Desensitizer Gel | EJK | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| December 14, 2018 | K182296 | HyperFil-LV | EBF | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| November 21, 2017 | K172176 | Parkell Universal Adhesive | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| September 18, 2015 | K151518 | BRUSH&BOND PLUS | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| February 24, 2015 | K142848 | EAZY PRIMER | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| April 12, 2012 | K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | MVL | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| June 10, 2010 | K101044 | RETRIEVE IMPLANT CEMENT | EMA | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| March 19, 2008 | K073698 | SECURE | EMA | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| November 28, 2006 | K063003 | AURORA | EBZ | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| June 15, 2006 | K060946 | CZ-S2000 | KIF | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| January 26, 2006 | K053516 | MUCOHARD | EBI | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| April 9, 2004 | K040599 | PARKELL RESIN GLAZE | EBD | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| March 20, 2002 | K020239 | TOUCH&BOND-PLUS | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| May 7, 2001 | K010475 | D/C CORE MATERIAL | EBF | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| October 25, 2000 | K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | ELR | Substantially Equivalent | Harald Nordin S.A | accessdata.fda.gov |
| August 30, 2000 | K002195 | FORAMATRON V, MODEL D680 | LQY | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| May 21, 1999 | K991270 | SMARTEMP | EBG | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| March 16, 1998 | K974865 | CSR | EBI | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| March 10, 1998 | K973679 | AEROETCHER | KOJ | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| December 4, 1997 | K973976 | EPIC-FLO | EBF | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| April 11, 1997 | K964867 | HYBRID RESIN COMPOSITE | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| September 6, 1996 | K962741 | TRI-PHASIX CHROMATIC ALGINATE | ELW | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| March 22, 1996 | K960879 | AMALGAMIBOND PLUS | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| February 26, 1996 | K960464 | C & B METABOND (MODIFICATION) | EMA | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| June 20, 1995 | K952123 | MS EMULSION | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| June 6, 1995 | K950239 | SENSIMATIC 500SE | EKZ | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| May 9, 1995 | K950238 | GENTAL PULSE | EAT | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| April 4, 1995 | K950256 | TURBO 25/30 | ELC | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| July 6, 1994 | K942017 | V-PRIMER | KLE | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| October 6, 1992 | K923867 | METAFIL | EBF | Substantially Equivalent | Parkell | accessdata.fda.gov |
| March 15, 1991 | K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Parkell | accessdata.fda.gov |
| April 12, 1990 | K900303 | CONNECT | EMA | Substantially Equivalent | Parkell | accessdata.fda.gov |
| February 22, 1990 | K896719 | PRIMER-P ADHESIVE AGENT | EBI | Substantially Equivalent | Parkell | accessdata.fda.gov |
| October 22, 1982 | K822896 | CAVIDRY | EJH | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| August 16, 1977 | K771527 | ACCU. CROWN COLD CURE | EBG | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Agent, Tooth Bonding, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Cement, Dental
- All makers of Post, Root Canal
- All makers of Unit, Electrosurgical, And Accessories, Dental
Updated August 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.