Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030378557

FEI Number

3030378557

Entity Name

Orikam Healthcare India Private Limited

City/State/Country

Gurgaon Haryana, IN

Establishment Address

Plot No. 620, Sector 37, Pace City 2, Gurgaon Haryana 122001, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Orikam Healthcare India Private Limited (Owner Number: 10089628)

Owner / Operator Contact Address

9753, 3RD FLOOR, AROGYAM BUILDING, NEAR SHEETLA HOSPITAL, NEW RAILWAY ROAD, SUBHASH NAGAR, Gurgaon, IN-HR 122001, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neoendo, Neoendo Gutta Percha Points, Gutta Percha Points Neoeondo MyEndo Glide File NEOENDO NEOTAPER NEOENDO FLEX GLIDE NEOENDO NEOBLUE Neoendo Flex Files MyEndo Neoendo Retreatment File MyEndo T Blue File Neoendo Neoglide Neoendo S MyEndo T File NEOENDO NEOHYBRID NEOENDO PEDOFLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-07-03
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Orikam Healthcare India Private Limited

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

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030378557. Last updated year: 2026. Please use registration number 3030378557 when referencing this establishment in official correspondence.