Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027584973

FEI Number

3027584973

Entity Name

F & A LABORATORIO FARMACEUTICO LTDA

City/State/Country

Sao Paulo-SP, BR

Establishment Address

Rua Machado de Assis, 470, Sao Paulo-SP 04106-001, BR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

F & A laboratorio Farmaceutico Ltda (Owner Number: 10092317)

Owner / Operator Contact Address

Rua Machado de Assis, 470, Sao Paulo-SP, BR-SP 04106-001, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PapaCarie Duo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2024-12-23
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2024-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

Teri Sturgell Business: Elevate Oral Care Email: tsturgell@elevateoralcare.com Phone: (561) 4602967

Related Public Records

Same Entity

F & A laboratorio Farmaceutico 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
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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2513595	MEDICAL PRODUCTS LABORATORIES, INC.	Philadelphia, PA, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3004967419	NU RADIANCE, INC.	Ashwaubenon, WI, US
3042272797	SOLVENTUM US LLC	Eagan, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027584973. Last updated year: 2026. Please use registration number 3027584973 when referencing this establishment in official correspondence.