Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004149016

FEI Number

3004149016

Entity Name

TOP OPERATOR PRODUCTS

City/State/Country

CAMBRIDGE Waikato, NZ

Establishment Address

2-88 Maungakawa Rd, RD4,, CAMBRIDGE Waikato 3496, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOP OPERATOR PRODUCTS (Owner Number: 9058541)

Owner / Operator Contact Address

2-88 MAUNGAKAWA ROAD, --, CAMBRIDGE, NZ-NOTA RD4 3496, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oneshot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2003-09-12

Official Correspondent

BEDE MCELWEE

US Agent Details

Emily Matorin Business: FDAbasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

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View consolidated registration, premarket clearance, and recall records for this applicant.

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Similar Registrations

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3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3015509619	DURR DENTAL SE	Bietigheim-Bissingen Baden-Wurttemberg, DE
3011944170	ZAPALIGN INC.	Anyang-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004149016. Last updated year: 2026. Please use registration number 3004149016 when referencing this establishment in official correspondence.