ELEGANT DIRECT CORP

FDA Device Registration & Listing · Brooklyn, NY, US · Registration 3013465593

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013465593
FEI Number
3013465593
Entity Name
ELEGANT DIRECT CORP
City/State/Country
Brooklyn, NY, US
Establishment Address
2308 McDonald Ave, Brooklyn, NY 11223, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ELEGANT DIRECT CORP (Owner Number: 10076895)
Owner / Operator Contact Address
2308 McDonald Ave, Brooklyn, NY 11223, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200355
PMA Number
N/A

All Registered Proprietary Names

DURANEXT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-08-04

Official Correspondent

GARY FINGERMAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELEGANT DIRECT CORP
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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013465593. Last updated year: 2026. Please use registration number 3013465593 when referencing this establishment in official correspondence.
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