Manufacturer registered with FDA

Parkell, Inc

Edgewood, NY, United States. Lists 27 dental device types with FDA across 1 registered establishment, and holds 58 510(k) clearances as applicant.

FDA owner/operator10047694Contract manufacturerManufacturerRepacker / relabelerSpecification developer2 clearances in five years

Device types listed: 27
Brands and models: 3
510(k) clearances: 581976–2025
Markets registered in: 12294 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 1976–2026

Registered in 12 markets

Where regulators' registries name Parkell, Inc as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Parkell, Inc	58 clearances	1976–2025	Below
Canada	Health Canada	Registration holder	PARKELL, INC.	139	2005–2025	Pure Global AI
European Union	EUDAMED	Manufacturer	Parkell Inc.	86	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Parkell Inc	23	—	Pure Global AI
South Korea	MFDS	Manufacturer	Parkell Inc.Parkell Inc · PARKELL INC.	19	1999–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	PARKELL INC.PARKELL, INC.	11	2005–2021	Pure Global AI
Brazil	ANVISA	Manufacturer	PARKELL INC.	6	2014–2023	Pure Global AI
Australia	TGA	Manufacturer	Parkell Inc	4	2004–2026	Pure Global AI
Hong Kong	MDD	Manufacturer	Parkell Inc.	2	2025–2026	Pure Global AI
Israel	AMAR	Manufacturer	Parkell, Inc.	2	—	Pure Global AI
China	NMPA	Registration holder	帕尔克（美国）有限公司Parkell,Inc.	1	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Parkell, Inc.	1	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Parkell, Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	—	2016
Dental CementEMA · Class 2	Dental cements	Maker	—	2016
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	—	2016
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	Etch-free	2016
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	Smartemp	2016
Impression MaterialELW · Class 2	Impression materials	Maker	—	2016
Pulp TesterEAT · Class 2	—	Maker	—	2016
Mouth MirrorEAX · Class 1	Dental hand instruments	Lister	—	2016
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	—	2026
Resin Filling Material CoatingEBD · Class 2	—	Maker	—	2016
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Lister	—	2016
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	—	2016
Orthodontic Preformed BandECM · Class 1	Orthodontic wires & bands	Lister	—	2016
Articulation PaperEFH · Class 1	—	Maker	—	2016
Silicate ProtectorEFX · Class 1	—	Lister	—	2016
Mercury and/or Alloy DispenserEHE · Class 1	—	Lister	—	2016
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Lister	—	2017
Base Metal AlloyEJH · Class 2	Dental alloys	Lister	—	2016
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	—	2021
Dental BurEJL · Class 1	Dental burs & diamonds	Lister	—	2016
ArticulatorsEJP · Class 1	Articulators & facebows	Lister	—	2016
Dental Electrosurgical Unit and AccessoriesEKZ · Class 2	—	Maker	—	2016
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Maker	—	2016
Root Canal PostELR · Class 1	Root canal filling materials	Lister	Resin post	2016
Preformed CrownELZ · Class 1	—	Lister	—	2016
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	—	2016
AirbrushKOJ · Class 2	—	Maker	—	2016

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Parkell, Inc as the applicant.

Decided	510(k)	Device	Device type
8 Aug 2025	K243254	Parkell Pit and Fissure Sealant	EBC Pit and Fissure Sealant and Conditioner
20 Jan 2022	K210259	Parkell Self-Adhesive Cement	EMA Dental Cement
22 Nov 2019	K191103	Parkell Desensitizer Gel	EJK Calcium Hydroxide Cavity Liner
5 Sep 2019	K190930	SmarTemp X1	EBG Resin Temporary Crown and Bridge
14 Dec 2018	K182296	HyperFil-LV	EBF Resin Tooth Shade Material
21 Nov 2017	K172176	Parkell Universal Adhesive	KLE Resin Tooth Bonding Agent
18 Sep 2015	K151518	BRUSH&BOND PLUS	KLE Resin Tooth Bonding Agent
24 Feb 2015	K142848	EAZY PRIMER	KLE Resin Tooth Bonding Agent
25 Jun 2014	K132115	ABSOLUTE DENTIN 2	EBF Resin Tooth Shade Material
10 Jun 2010	K101044	RETRIEVE IMPLANT CEMENT	EMA Dental Cement
13 May 2008	K080549	DURAFINISH ALL-CURE, MODEL S296	EBD Resin Filling Material Coating
19 Mar 2008	K073698	SECURE	EMA Dental Cement
4 Dec 2006	K062518	CELERITY	EBF Resin Tooth Shade Material
28 Nov 2006	K063003	AURORA	EBZ Ultraviolet Activator for Polymerization
15 Jun 2006	K060946	CZ-S2000	KIF Root Canal Filling Resin
26 Jan 2006	K053516	MUCOHARD	EBI Rebasing Repairing Relining Denture Resin
9 Apr 2004	K040599	PARKELL RESIN GLAZE	EBD Resin Filling Material Coating
9 Sep 2003	K032179	COMP. E	KLE Resin Tooth Bonding Agent
11 Jul 2003	K031212	TEMPORARY RESIN CEMENT	EMA Dental Cement
6 Sep 2002	K022097	THERMIQUE	EAT Pulp Tester
20 Mar 2002	K020239	TOUCH&BOND-PLUS	KLE Resin Tooth Bonding Agent
6 Sep 2001	K012360	LC TEMPORARY FILLING	EBG Resin Temporary Crown and Bridge
7 May 2001	K010475	D/C CORE MATERIAL	EBF Resin Tooth Shade Material
7 Feb 2000	K994302	RESIN TOOTH BONDING AGENT	KLE Resin Tooth Bonding Agent
21 May 1999	K991270	SMARTEMP	EBG Resin Temporary Crown and Bridge
17 May 1999	K990381	TOTALBOND	EMA Dental Cement
21 Dec 1998	K983413	MODEL MS-1 HANDPIECE	EKX Ac-Powered Direct Drive Handpiece
2 Sep 1998	K982050	MODEL MS-2 HANDPIECE	EFB Dental Air-Powered Handpiece
16 Mar 1998	K974865	CSR	EBI Rebasing Repairing Relining Denture Resin
10 Mar 1998	K973679	AEROETCHER	KOJ Airbrush
4 Dec 1997	K973976	EPIC-FLO	EBF Resin Tooth Shade Material
6 Nov 1997	K973200	CARIES STAIN	LFC Caries Detection Device
29 Aug 1997	K972421	EASY BOND	KLE Resin Tooth Bonding Agent
11 Apr 1997	K964867	HYBRID RESIN COMPOSITE	KLE Resin Tooth Bonding Agent
6 Sep 1996	K962741	TRI-PHASIX CHROMATIC ALGINATE	ELW Impression Material
22 Mar 1996	K960879	AMALGAMIBOND PLUS	KLE Resin Tooth Bonding Agent
26 Feb 1996	K960464	C & B METABOND (MODIFICATION)	EMA Dental Cement
20 Jun 1995	K952124	ABOND	KLE Resin Tooth Bonding Agent
20 Jun 1995	K952123	MS EMULSION	KLE Resin Tooth Bonding Agent
9 Jun 1995	K950237	DIGITEST	EAT Pulp Tester
6 Jun 1995	K950239	SENSIMATIC 500SE	EKZ Dental Electrosurgical Unit and Accessories
9 May 1995	K950238	GENTAL PULSE	EAT Pulp Tester
10 Apr 1995	K950905	C&B-METABOND RADIOPAQUE POWDER	KLE Resin Tooth Bonding Agent
4 Apr 1995	K950256	TURBO 25/30	ELC Ultrasonic Scaler
4 Apr 1995	K950240	LE CLEAN MACHINE	ELC Ultrasonic Scaler
6 Jul 1994	K942017	V-PRIMER	KLE Resin Tooth Bonding Agent
20 Oct 1993	K933547	INTRA-ORAL IRRIGATOR	ELC Ultrasonic Scaler
6 Oct 1992	K923867	METAFIL	EBF Resin Tooth Shade Material
15 Mar 1991	K905032	MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL	ELW Impression Material
12 Apr 1990	K900303	CONNECT	EMA Dental Cement
22 Feb 1990	K896719	PRIMER-P ADHESIVE AGENT	EBI Rebasing Repairing Relining Denture Resin
21 Dec 1989	K895750	HEMA-PRIMER	KLE Resin Tooth Bonding Agent
7 Jun 1989	K892003	ABRAKADABRA - DENTAL ADHESIVE SYSTEM	KLE Resin Tooth Bonding Agent
13 Feb 1989	K884918	PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER	KLE Resin Tooth Bonding Agent
15 Jul 1988	K881914	COVER UP	EMA Dental Cement
1 Jul 1985	K852540	ULTRASONIC TOOTH SCALER MODEL DSCIOP	ELC Ultrasonic Scaler
9 Jan 1980	K792363	SILAGUM	ELW Impression Material
21 Oct 1976	K760723	SAFE-T-PINS RETENTIVE PIN SYSTEM	EBL Retentive and Splinting Pin and Accessory Instruments

Also lists devices cleared under other names

Parkell, Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Parker Laboratories, Inc. (2), Harald Nordin S.A (1).

Decided	510(k)	Device	Applicant	Device type
25 Oct 2000	K003221	HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST	Harald Nordin S.A	ELR Root Canal Post
22 Oct 1982	K822896	CAVIDRY	Parker Laboratories, Inc.	EJH Base Metal Alloy
16 Aug 1977	K771527	ACCU. CROWN COLD CURE	Parker Laboratories, Inc.	EBG Resin Temporary Crown and Bridge

Registered establishments

Establishment	Location	What it does
PARKELL, INC.FDA reg. 2411797	EDGEWOOD, NY, United States	Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10047694). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.