Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003009016

FEI Number

3003009016

Entity Name

INNOBRACE ORTHODONTICS PTE LTD

City/State/Country

SINGAPORE Central Singapore, SG

Establishment Address

28 Senang Crescent, #02-01/02, Bizhub 28, SINGAPORE Central Singapore 416601, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOBRACE ORTHODONTICS PTE LTD (Owner Number: 9052266)

Owner / Operator Contact Address

28 Senang Crescent, #02-01/02, Bizhub 28, --, SINGAPORE, SG-01 416601, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EPSILON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2002-07-25

Official Correspondent

Jessie Tay

US Agent Details

ROBERT CLANDI Business: PROCUREMENT PARTNERS INTERNATIONAL, INC. Email: rob@thesourcepros.com Phone: (650) 3456118

Related Public Records

Same Entity

INNOBRACE ORTHODONTICS PTE LTD

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003009016. Last updated year: 2026. Please use registration number 3003009016 when referencing this establishment in official correspondence.