Parkell, Inc.
Medical device manufacturer in Edgewood, NJ.
61510(k) clearances
0PMA approvals
0recalls
Device types
- KLE Agent, Tooth Bonding, Resin 16
- EMA Cement, Dental 8
- EBF Material, Tooth Shade, Resin 6
- ELC Scaler, Ultrasonic 4
- ELW Material, Impression 3
- EBI Resin, Denture, Relining, Repairing, Rebasing 3
- EAT Tester, Pulp 3
- EBG Crown And Bridge, Temporary, Resin 3
- LQY Locator, Root Apex 2
- EBD Coating, Filling Material, Resin 2
- EBC Sealant, Pit And Fissure, And Conditioner 1
- EBL Pin, Retentive And Splinting, And Accessory… 1
- EJK Liner, Cavity, Calcium Hydroxide 1
- MVL Cord, Retraction 1
- EBZ Activator, Ultraviolet, For Polymerization 1
- KIF Resin, Root Canal Filling 1
- EKX Handpiece, Direct Drive, Ac-Powered 1
- EFB Handpiece, Air-Powered, Dental 1
- KOJ Airbrush 1
- LFC Device, Caries Detection 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
| K101044 | Retrieve Implant CementEMA · Traditional | 06/10/2010SE |
| K080549 | Durafinish All-Cure, Model S296EBD · Traditional | 05/13/2008SE |
| K073698 | SecureEMA · Traditional | 03/19/2008SE |
| K062518 | CelerityEBF · Traditional | 12/04/2006SE |
| K063003 | AuroraEBZ · Traditional | 11/28/2006SE |
| K060946 | CZ-S2000KIF · Traditional | 06/15/2006SE |
| K053516 | MucohardEBI · Traditional | 01/26/2006SE |
| K040599 | Parkell Resin GlazeEBD · Traditional | 04/09/2004SE |
| K032179 | Comp. EKLE · Traditional | 09/09/2003SE |
| K031212 | Temporary Resin CementEMA · Traditional | 07/11/2003SE |
| K022097 | ThermiqueEAT · Traditional | 09/06/2002SE |
| K020239 | Touch&Bond-PlusKLE · Traditional | 03/20/2002SE |
| K012360 | LC Temporary FillingEBG · Traditional | 09/06/2001SE |
| K010475 | D/C Core MaterialEBF · Traditional | 05/07/2001SE |
| K002195 | Foramatron V, Model D680LQY · Traditional | 08/30/2000SE |
| K994302 | Resin Tooth Bonding AgentKLE · Traditional | 02/07/2000SE |
| K991270 | SmartempEBG · Traditional | 05/21/1999SE |
| K990381 | TotalbondEMA · Traditional | 05/17/1999SE |
| K983413 | Model MS-1 HandpieceEKX · Traditional | 12/21/1998SE |
| K982050 | Model MS-2 HandpieceEFB · Traditional | 09/02/1998SE |
| K974865 | CSREBI · Traditional | 03/16/1998SE |
| K973679 | AeroetcherKOJ · Traditional | 03/10/1998SE |
| K973976 | Epic-FloEBF · Traditional | 12/04/1997SE |
| K973200 | Caries StainLFC · Traditional | 11/06/1997SE |
| K972421 | Easy BondKLE · Traditional | 08/29/1997SE |
| K964867 | Hybrid Resin CompositeKLE · Traditional | 04/11/1997SE |
| K962741 | Tri-Phasix Chromatic AlginateELW · Traditional | 09/06/1996SE |
| K960879 | Amalgamibond PlusKLE · Traditional | 03/22/1996SE |
| K960464 | C & B Metabond (Modification)EMA · Traditional | 02/26/1996SE |
| K952124 | AbondKLE · Traditional | 06/20/1995SE |
| K952123 | MS EmulsionKLE · Traditional | 06/20/1995SE |
| K950237 | DigitestEAT · Traditional | 06/09/1995SE |
| K950239 | Sensimatic 500SEEKZ · Traditional | 06/06/1995SE |
| K950238 | Gental PulseEAT · Traditional | 05/09/1995SE |
| K950857 | Foramatron IVLQY · Traditional | 04/20/1995SE |
| K950905 | C&B-Metabond Radiopaque PowderKLE · Traditional | 04/10/1995SE |
| K950256 | Turbo 25/30ELC · Traditional | 04/04/1995SE |
| K950240 | Le Clean MachineELC · Traditional | 04/04/1995SE |
| K942017 | V-PrimerKLE · Traditional | 07/06/1994SE |
| K933547 | Intra-Oral IrrigatorELC · Traditional | 10/20/1993SE |
| K923867 | MetafilEBF · Traditional | 10/06/1992SE |
| K905032 | Mousse, Polyvinyl Siloxane Impression MaterialELW · Traditional | 03/15/1991SE |
| K900303 | ConnectEMA · Traditional | 04/12/1990SE |
| K896719 | Primer-P Adhesive AgentEBI · Traditional | 02/22/1990SE |
| K895750 | Hema-PrimerKLE · Traditional | 12/21/1989SE |
| K892003 | Abrakadabra - Dental Adhesive SystemKLE · Traditional | 06/07/1989SE |
| K884918 | Porcelain Etching Gel and Etching Gel BarrierKLE · Traditional | 02/13/1989SE |
| K881914 | Cover UpEMA · Traditional | 07/15/1988SE |
| K852540 | Ultrasonic Tooth Scaler Model DsciopELC · Traditional | 07/01/1985SE |
| K792363 | SilagumELW · Traditional | 01/09/1980SE |
| K760723 | Safe-T-Pins Retentive Pin SystemEBL · Traditional | 10/21/1976SE |