Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003092374

FEI Number

3003092374

Entity Name

TECNIDENT EQUIPAMENTOS ORTODONTICOS LTDA.

City/State/Country

SAO CARLOS Sao Paulo, BR

Establishment Address

Rua Lourenco Inocentini 751, Vila Nery, SAO CARLOS Sao Paulo 13567-620, BR

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

TECNIDENT EQUIPAMENTOS ORTODONTICOS LTDA. (Owner Number: 9055367)

Owner / Operator Contact Address

Rua Lourenco Inocentini 751, Sao Carlos, BR-SP 13567-620, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tecnident TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS TECNIDENT EQUIPAMENTOS ORTODONTICOS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2008-02-01
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2003-03-06
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2003-03-06
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2003-03-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2003-03-06
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2003-03-06
KCR	Facebow	Dental	Class 1	872.3220	2003-03-06
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2003-03-06

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

TECNIDENT EQUIPAMENTOS ORTODONTICOS 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

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1000379569	Wire and Cable Specialties, Inc.	Coatesville, PA, US
3038252913	ADVANCED ORTHODONTIC SOLUTIONS	Tampa, FL, US
3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3009827000	WHITE OAK ORTHODONTIC PRODUCTS	Mount Joy, PA, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003092374. Last updated year: 2026. Please use registration number 3003092374 when referencing this establishment in official correspondence.