Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004961419

FEI Number

3004961419

Entity Name

GENESIS DENTAL TECHNOLOGIES, LLC

City/State/Country

ELMWOOD, WI, US

Establishment Address

200 MAIN STREET, ELMWOOD, WI 54740, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GENESIS DENTAL TECHNOLOGIES, LLC (Owner Number: 9068712)

Owner / Operator Contact Address

200 MAIN STREET, --, ELMWOOD, WI 54740, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K934436

PMA Number

N/A

All Registered Proprietary Names

AQUASEPT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GENESIS DENTAL TECHNOLOGIES, LLC

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

View Entity Profile →

Similar Registrations

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3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004961419. Last updated year: 2026. Please use registration number 3004961419 when referencing this establishment in official correspondence.