Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2411797

FEI Number

2411797

Entity Name

PARKELL, INC.

City/State/Country

EDGEWOOD, NY, US

Establishment Address

300 EXECUTIVE DR., EDGEWOOD, NY 11717, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Parkell, Inc (Owner Number: 10047694)

Owner / Operator Contact Address

300 Executive Drive, Edgewood, NY 11717, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973679

PMA Number

N/A

All Registered Proprietary Names

Etch-free Resin post Smartemp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQY	Locator, Root Apex	Unknown	Class U	N/A	2016-10-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-10-18
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2016-10-18
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2016-10-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-10-18
ELW	Material, Impression	Dental	Class 2	872.3660	2016-10-18
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2016-10-18
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2016-10-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-11-15
MVL	Cord, Retraction	Unknown	Class U	N/A	2016-10-18
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2016-10-18
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2017-04-12
EFX	Protector, Silicate	Dental	Class 1	872.6670	2016-10-18
EJL	Bur, Dental	Dental	Class 1	872.3240	2016-10-18
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2024-12-17
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-10-18
EKZ	Unit, Electrosurgical, And Accessories, Dental	Dental	Class 2	872.4920	2016-10-18
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2016-10-18
EAT	Tester, Pulp	Dental	Class 2	872.1720	2016-10-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-11-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2022-02-15
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2016-10-18
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2021-11-15
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2016-10-18
EHE	Dispenser, Mercury And/Or Alloy	Dental	Class 1	872.3080	2016-10-18
ELR	Post, Root Canal	Dental	Class 1	872.3810	2016-10-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-11-15
EJP	Articulators	Dental	Class 1	872.3150	2016-10-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-10-18
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2016-10-18
ELW	Material, Impression	Dental	Class 2	872.3660	2016-10-18
EFH	Paper, Articulation	Dental	Class 1	872.6140	2016-10-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-11-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-11-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-10-18
KOJ	Airbrush	Dental	Class 2	872.6080	2016-10-18

Official Correspondent

Yasily Ogando Roa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Parkell, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2411797. Last updated year: 2026. Please use registration number 2411797 when referencing this establishment in official correspondence.