Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032027578

FEI Number

3032027578

Entity Name

Solventum Orthodontics Corporation

City/State/Country

Monrovia, CA, US

Establishment Address

2724 South Peck Rd., Monrovia, CA 91016, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Solventum US LLC (Owner Number: 10091183)

Owner / Operator Contact Address

12930 IH 10 West, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Boone Bracket Positioning Gauge Bracket Positioning Gauges Orthodontic Elastics Action Line Thread and Tubing Lingual Rotation Wedge AlastiK Ligatures, Chain, Separators, Modules Incognito Indirect Bonding Tray Unitek Traction Release Headgear Friction-Stop Adjustage Facebow Level Anchorage Facebow NWO Snap-way Series 5 Facebow NWO Headgear Unitek Multi-Cure Glass Ionomer Orthodontic Band Cement Mouth Mirror Unitek SILVER SOLDER Clarity Burs OPTICLUDE ORTHOPTIC EYE PATCH OPTICLUDE 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch 3M(TM) Nexcare(TM) Gentle Removal Eye Patch Molar Band Seater Unitek Orthodontic Wax Incognito Hi-T Unitek

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2013-04-02
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	1992-12-03
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1992-12-03
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	1992-12-03
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	1999-03-19
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2025-06-26
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2002-03-05
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2007-11-28
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2007-11-27
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2007-11-27
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2007-11-27
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-03-21
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2007-11-27
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	1992-12-03
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-28
EAX	Mirror, Mouth	Dental	Class 1	872.4565	1992-12-03
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	1992-12-03
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1992-12-03
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2020-02-04
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2007-12-03
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-03-29
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2018-03-29
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2012-02-07
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2012-02-07
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2012-02-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-06
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2007-11-27
EJL	Bur, Dental	Dental	Class 1	872.3240	2003-11-26
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-08-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-09-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1978-03-31
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1978-08-31
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1992-12-03
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1992-12-03
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-09-19
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-12-04
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2011-03-24
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	1999-03-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-28
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1992-12-03

Official Correspondent

JEFFERY SCHORR

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solventum US LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004943440	3M Purification, S. de R.L. de C. V.	San Luis Potosi Mexico, MX
3003775292	KCI POLYMEDICS BV	PEER Limburg, BE
3036108847	Solventum US LLC	Eden Prairie, MN, US
3038988287	Solventum Canada Limited	Morden Manitoba, CA
3032763783	Solventum Poland Manufacturing SP. ZO.O	Wroclaw Dolnoslaskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K875144	Reliance Orthodontic Products, Inc.	EXCEL FAST SET	1988-02-26

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.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032027578. Last updated year: 2026. Please use registration number 3032027578 when referencing this establishment in official correspondence.