Ormco Corporation

FDA Device Registration & Listing · Pomona, CA, US · Registration 3013508670

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
3013508670
FEI Number
2024258
Entity Name
Ormco Corporation
City/State/Country
Pomona, CA, US
Establishment Address
1937 W. Mission Blvd., Pomona, CA 91766, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
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

CLAMP WIRE ORTHODONTIC EndoRing SimpliCore Universal Verifier SimpliCore Verifier for Zenflex One Spark Clear Aligner System Water Cooled Impression Tray Originate Impression Trays Putty Spacer Three-In-One Impression Trays Clear Impression Trays Ormco Digital Bonding

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 1982-12-15
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2011-09-14
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 1989-05-22
EMA Cement, Dental Dental Class 2 872.3275 2019-11-27
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 1982-12-15
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2012-08-09
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2012-08-09
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2012-08-09
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-11-29
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2025-04-23
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2003-08-05
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2007-11-05
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2015-04-22
DZD Tube, Orthodontic Dental Class 1 872.5410 2003-12-22
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2007-09-07
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-08-05
ECO Spring, Orthodontic Dental Class 1 872.5410 1982-12-15
PNN Orthodontic Software Dental Class 2 872.5470 2021-04-20
NXC Aligner, Sequential Dental Class 2 872.5470 2021-04-20
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1977-12-15
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2007-11-05
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2020-03-12
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2013-03-21
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2013-03-21
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2013-03-21
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2013-03-29
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2013-03-29
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2013-03-29
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
NXC Aligner, Sequential Dental Class 2 872.5470 2018-11-01
EIS Remover, Crown Dental Class 1 872.4565 2004-10-25
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 1978-02-15
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2023-11-17
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2010-11-29
EAX Mirror, Mouth Dental Class 1 872.4565 1996-10-02
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2012-11-21
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-13
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2002-07-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-05
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2018-02-21
NXC Aligner, Sequential Dental Class 2 872.5470 2025-07-02
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2023-09-26
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2003-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09
K940030 Bisco, Inc. BISCO COMPOSITE 1994-02-04

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 307850***DISTRIBUTED 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 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013508670. Last updated year: 2026. Please use registration number 3013508670 when referencing this establishment in official correspondence.
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