Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011618875

FEI Number

3011618875

Entity Name

BLUE DENT DENTAL

City/State/Country

Pirassununga Sao Paulo, BR

Establishment Address

Rua Joaguim Jorge Port, 1272, Pirassununga Sao Paulo 13-636-142, BR

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Blue Dent Dental (Owner Number: 10055653)

Owner / Operator Contact Address

Rua Joaguim Jorge Port, 1272, Pirassununga, BR-SP 13-636-142, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182065

PMA Number

N/A

All Registered Proprietary Names

Denture, plastic, teeth CROWN AND BRIDGE, TEMPORARY, RESIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2017-09-05
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2018-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

Blue Dent Dental

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011618875. Last updated year: 2026. Please use registration number 3011618875 when referencing this establishment in official correspondence.