Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022112716

FEI Number

3022112716

Entity Name

PHS DO BRASIL LTDA

City/State/Country

Joinville Santa Catarina, BR

Establishment Address

Guilherme Boldt Street, 210 - Zona Industrial Norte, Joinville Santa Catarina 89239-260, BR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PHS Do Brasil LTDA (Owner Number: 10084634)

Owner / Operator Contact Address

Guilherme Boldt Street, 210 - Zona Industrial Norte, Joinville, BR-SC 89239-260, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Potenza Esente HF - Acid Conditioner Potenza Attacco HF Potenza Specchi Potenza Blocco Potenza Abrasione ACID CONDITIONER 35% Acid Conditioner Potenza Attacco Condicionador Acido 35% ACID CONDITIONER 37% - Acid Conditioner Potenza Attacco Condicionador Acido 37% Potenza Bianco CONDITIONER 37% - Acid Conditioner HF - Acid Conditioner ACID CONDITIONER 35% - Acid Conditioner

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	2022-03-15
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2022-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PHS Do Brasil LTDA

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
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 3022112716. Last updated year: 2026. Please use registration number 3022112716 when referencing this establishment in official correspondence.