Ormex S. de R.L. de C.V.

FDA Device Registration & Listing · YUCATAN UMAN, MX · Registration 8030637

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8030637
FEI Number
3002807826
Entity Name
Ormex S. de R.L. de C.V.
City/State/Country
YUCATAN UMAN, MX
Establishment Address
CALLE 21, No. 1103, AMPLIACION, CIUDAD IND., YUCATAN UMAN 97390, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)
Owner / Operator Contact Address
1889 W Mission Blvd, --, Pomona, CA 91766, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Reamers Pulp Canal TF Adaptive Files Traverse Files TF (Twisted Files) ZenFlex Files Triple Flex Files K-Files LA Axxess Hedstrom Files Barbed Broach Pathfinder K-Flex Files Pathfinder CS K3XF Files Quantec Files ZenFlex One Sterile and Non-Sterile Files Traverse Orifice and Glide Path File Quantec Axxess Files Traverse Orifice Opener LightSpeed LSX K3 Files Root Canal Reamers LightSpeed CRX Traverse Glide Path File Finger Spreaders Chamfer Preparation Logic Set Veneer Preparation Logic Set Axial Reduction - MADC Raintree Essix Logic Set Zir-CUT Substructure Logic Set CEREC Starter Logic Set Belvedere C.C.V. Logic Set CEREC Prep N' Glaze Logic Set TDF Diamond Logic Set All Ceramic Logic Set LVI Anterior Direct Ressin Preparation Logic Set Hornbrool Prep Logic Set Anterior Composite Logic Set Laminate Veneer Logic Set Axial Reduction Logic Set TDF Series Composite Logic Set LA Axxess Nano Diamonds CEREC Prep & Finish Logic Set ZIR-CUT Diamond Bambino Diamonds KS Series Guide Pin Diamond Intensiv ProxoShape Diamond File Zir-Cut DDS Adjusting Logic Set Nano Prep Diamond Logic Set Personalized Logic Set Turbo Chamfer Preparation Logic Set BruxZir Logic Set Reverse Preparation Logic Set TDF Series Hornbrook Finish Logic Set Logic Set Axis Diamond Burs CEREC Intra-Oral Art & Passion Logic Set R.A.P.T.O.R. Diamond Modified Shoulder Logic Set Turbo Diamonds LAVA Preparation Logic Set Composite Logic Set LVI Esthetic Preparation Logic Set cerecdoctors.com Logic Set Radz & Soileau RSVP Logic Set BluWhite SimpliCut Pre-Sterile Diamond Burs

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2003-08-05
DZC Wire, Orthodontic Dental Class 1 872.5410 2002-07-02
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2002-07-02
DZD Tube, Orthodontic Dental Class 1 872.5410 2003-12-22
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1996-10-02
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 1996-10-02
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2014-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

Procoro Herrera Business: Sybron Dental Specialties Inc. Email: SybronDentalSpecialtiesRA@envistaco.com Phone: (657) 3416074

Related Public Records

Same Entity

SYBRON DENTAL SPECIALTIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027500898 EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada Escazu, San Rafael San Jose, CR
3003848022 Metrex Research LLC Madison, WI, US
1722021 METREX RESEARCH Romulus, MI, US
3031606517 Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan, CN
3028340833 EH Labs CZ s.r.o. Dvur Kralove nad Labem Hradec Kralove, CZ

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
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030637. Last updated year: 2026. Please use registration number 8030637 when referencing this establishment in official correspondence.
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