Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008005217

FEI Number

3008005217

Entity Name

US ORTHODONTIC PRODUCTS

City/State/Country

Norwalk, CA, US

Establishment Address

11917 Front Street, Norwalk, CA 90650, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

US Orthodontic Products (Owner Number: 10036473)

Owner / Operator Contact Address

11917 Front Street, Norwalk, CA 90650, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elastic Band Tooth Bonding Resin Impression Tray Orthodontic Band Resin Tooth Shade Material Saliva Ejector Orthodontic Spring Orthodontic Plier Orthodontic Band Orthodontic Wire Dental Instrument BRACKET, AESTHETIC, ORTHODONTICS BRACKET, METAL ORTHODONTIC Orthodontic Tube Matrix Contouring Instrument Adhesive Bracket and Tooth Conditioner Resin Retainer, Mouthguard, Bite Guard Tooth Shade Resin Material Mouth Mirror

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2012-02-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-05-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2012-02-07
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-05-13
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2020-05-13
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2012-02-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-05-10
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2012-02-07
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2012-02-07
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2013-11-11
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2012-02-07
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2012-02-07
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2011-05-10
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-02-07
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2015-08-10
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-13
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-05-08
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2012-02-07
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2020-05-13
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2012-02-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-05-10
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2012-01-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-05-10
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2011-05-10
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2012-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

US Orthodontic Products

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

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.
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.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

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3009491780	Phoenix Orthodontics Inc	Marietta, GA, US
1833132	G & H Wire Company	Franklin, IN, US
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US
3008882689	Xplora USA LLC	Carrollton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008005217. Last updated year: 2026. Please use registration number 3008005217 when referencing this establishment in official correspondence.