Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003697084

FEI Number

3003697084

Entity Name

VELOPEX INTERNATIONAL, INC.

City/State/Country

Saint Cloud, FL, US

Establishment Address

105 EAST 17TH ST., Saint Cloud, FL 34769, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MEDIVANCE INSTRUMENTS LTD. (Owner Number: 9051184)

Owner / Operator Contact Address

BARRETT'S GREEN ROAD, --, HARLESDEN, LONDON, GB-NOTA NW10 7AP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAG 45S5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-07-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDIVANCE INSTRUMENTS LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003982003	MEDIVANCE INSTRUMENTS LTD.	HARLESDEN, LONDON London, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003697084. Last updated year: 2026. Please use registration number 3003697084 when referencing this establishment in official correspondence.