Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027344570

FEI Number

3027344570

Entity Name

ENDO DIRECT, LLC

City/State/Country

Monroe, NJ, US

Establishment Address

24 Abeel Rd, Monroe, NJ 08831, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Endo Direct, LLC (Owner Number: 10088054)

Owner / Operator Contact Address

24 Abeel Rd, Monroe, NJ 08831, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221811

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2023-05-22
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2023-05-22
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-12-06
EKM	Gutta-Percha	Dental	Class 1	872.3850	2023-05-22
ELR	Post, Root Canal	Dental	Class 1	872.3810	2025-12-06
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2023-05-22
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-05-22
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-05-22
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2023-05-22

Official Correspondent

A. Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endo Direct, LLC

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020	Inter-Med Llc	U	Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

Similar Registrations

Registration Number	Establishment Name	Location
9612827	BIORA AB	MALMO Skane, SE
2024024	Sterigenics Radiation Technologies, LLC	San Diego, CA, US
2320721	TULSA DENTAL PRODUCTS LLC	Johnson City, TN, US
3026760	JORDCO, INC.	Hillsboro, OR, US
2245590	Sterigenics U.S., LLC	Salem, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027344570. Last updated year: 2026. Please use registration number 3027344570 when referencing this establishment in official correspondence.