Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681207

FEI Number

3001682269

Entity Name

DENTAL MORELLI LTDA.

City/State/Country

SOROCABA Sao Paulo, BR

Establishment Address

ALAMEDA JUNDIAI,230/250, JD.SAIRA, SOROCABA Sao Paulo 18085.090, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DENTAL MORELLI LTDA. (Owner Number: 9020620)

Owner / Operator Contact Address

Alameda Jundiai,230/250, JD. Saira, Sorocaba, BR-SP 18085-090, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHO	Bar, Preformed	Dental	Class 1	872.3165	2016-10-13
EHL	Point, Abrasive	Dental	Class 1	872.6010	2018-11-30
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2007-04-02
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2012-03-02
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2013-10-31
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2006-06-13
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2025-11-27
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2013-10-31
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2016-10-13
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2000-10-13
KCR	Facebow	Dental	Class 1	872.3220	2000-10-13
EIG	Retractor, All Types	Dental	Class 1	872.4565	2000-10-13
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-10-13
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2014-01-20
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2000-10-13
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-10-31
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2016-10-13
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2000-10-13
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2000-10-13

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

DENTAL MORELLI 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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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3026401444	HADER Solutions & Distribution Ltd	Swords CO Dublin, IE
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681207. Last updated year: 2026. Please use registration number 9681207 when referencing this establishment in official correspondence.