Ultra Distributors

FDA Device Registration & Listing · Somerset, NJ, US · Registration 3012773447

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
3012773447
FEI Number
3012773447
Entity Name
Ultra Distributors
City/State/Country
Somerset, NJ, US
Establishment Address
142 Belmont Drive, Unit # 8, Somerset, NJ 08873, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Orazen Inc (Owner Number: 10058068)
Owner / Operator Contact Address
142 Belmont Drive, Unit # 8, Somerset, NJ 08873, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Orazen

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFW Toothbrush, Manual Dental Class 1 872.6855 2018-08-10
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-09-27

Official Correspondent

Ria Angras

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orazen 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
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

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3043840120 CURIDENT, LLC Boca Raton, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012773447. Last updated year: 2026. Please use registration number 3012773447 when referencing this establishment in official correspondence.
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