Ormco Corporation

FDA Device Registration & Listing · Brea, CA, US · Registration 3015272949

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
3015272949
FEI Number
3015272949
Entity Name
Ormco Corporation
City/State/Country
Brea, CA, US
Establishment Address
200 S. Kraemer Blvd, --, Brea, CA 92821, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)
Owner / Operator Contact Address
1889 W Mission Blvd, --, Pomona, CA 91766, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K943245
PMA Number
N/A

All Registered Proprietary Names

Disposable Applicators Brushes Bite Wafer Disclosing Wax Occlusal Indicator Wax TF Adaptive Paper Points K3/K3XF Paper Points ZenFlex ONE Paper Points TF Paper Points Autofit Paper Points PAPER POINTS Lythos Spark Clear Aligner System elements e-motion Ormco Digital Bonding Water Cooled Impression Tray Originate Impression Trays Putty Spacer Three-In-One Impression Trays Clear Impression Trays EndoRing SimpliCore Universal Verifier SimpliCore Verifier for Zenflex One Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2003-12-22
KXR Applicator, Resin Dental Class 1 872.3140 2008-12-01
ECO Spring, Orthodontic Dental Class 1 872.5410 1982-12-15
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 1977-12-15
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2010-11-29
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2017-09-21
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2017-09-21
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
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2009-07-27
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-13
EMA Cement, Dental Dental Class 2 872.3275 2019-11-27
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-05
EAX Mirror, Mouth Dental Class 1 872.4565 1996-10-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
JEX Plier, 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
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 1978-02-15
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 1982-12-15
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2015-04-22
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2005-11-14
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2013-02-25
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2025-04-23
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 1982-12-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-08-05
PNN Orthodontic Software Dental Class 2 872.5470 2021-04-20
NXC Aligner, Sequential Dental Class 2 872.5470 2021-04-20
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 2002-07-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2012-11-29
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2018-02-21
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2012-11-21
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2019-04-18
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2007-11-05
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2007-11-05
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2023-09-26
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2019-07-16
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1977-12-15
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2003-08-05
EIS Remover, Crown Dental Class 1 872.4565 2004-10-25
DZN Instruments, Dental Hand Dental Class 1 872.4565 2005-08-10
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 1982-12-15
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
DZC Wire, Orthodontic Dental Class 1 872.5410 2002-07-02
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2011-09-14

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
K180404 3M Healthcare 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 2018-03-16
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13
K161684 Reliance Orthodontic Products, Inc. Quantum LB 2016-10-06
K810210 Sci-Pharm, Inc. MAGIC-TOUCH 1981-02-10

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.
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015272949. Last updated year: 2026. Please use registration number 3015272949 when referencing this establishment in official correspondence.
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