Data / Medical devices / United States / Solventum Orthodontics Corporation
Solventum Orthodontics Corporation: FDA-registered device maker in Monrovia, CA, United States, 18 510(k) clearances
Solventum Orthodontics Corporation is registered with the FDA (registration 3032027578) in Monrovia, CA, United States. It lists 37 device types. The FDA files 18 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032027578
- Address
- 2724 South Peck Rd., Monrovia, CA, United States, 91016
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- March 31, 1978
- Registered through
- 2026
- Brand names listed
- 3M Unitek, 3M(TM) Nexcare(TM) Gentle Removal Eye Patch, 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch, Action Line Thread and Tubing, AlastiK Ligatures, Chain, Separators, Modules, Boone Bracket Positioning Gauge, Bracket Positioning Gauges, Burs and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Band, Material, Orthodontic | DYO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Headgear, Extraoral, Orthodontic | DZB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract manufacturer, Manufacturer for export | accessdata.fda.gov |
| Tube Impression And Matrix | KCQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2023 | K234043 | 3M Transbond Orthodontic Adhesive | DYH | Substantially Equivalent | 3M Unitek Orthodontic Products | accessdata.fda.gov |
| September 29, 2023 | K233257 | 3M ClarityAligners with Quick Attachments | NXC | Substantially Equivalent | 3M Company, Unitek Orthodontic Products | accessdata.fda.gov |
| May 22, 2023 | K231464 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | NXC | Substantially Equivalent | 3M Company, Unitek Orthodontic Products | accessdata.fda.gov |
| September 5, 2019 | K192119 | 3M Clarity Aligners | NXC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 16, 2018 | K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | NJM | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| February 2, 2012 | K113197 | APC FLASH-FREE ADHESIVE | DYH | Substantially Equivalent | 3M Unitek Corporation | accessdata.fda.gov |
| February 17, 2011 | K102803 | CLARITY ADVANCED CERAMIC BRACKETS | NJM | Substantially Equivalent | 3M Unitek Corporation | accessdata.fda.gov |
| February 15, 2008 | K073697 | TRANSBOND SUPREME ADHESIVE | DYH | Substantially Equivalent | 3M Unitek | accessdata.fda.gov |
| April 12, 2002 | K020394 | APC PLUS ADHESIVE | DYH | Substantially Equivalent | 3M Unitek | accessdata.fda.gov |
| May 16, 2001 | K011154 | ELIPAR FREELIGHT | EBZ | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| July 7, 2000 | K001494 | MODIFICATION TO PROMPT L-POP | KLE | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| April 30, 1997 | K970500 | 3M SUSTEL DENTAL SYSTEM | EBF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| August 12, 1996 | K962785 | 3M DENT SYSTEM | KLE | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 7, 1995 | K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | DYH | Substantially Equivalent | 3M Unitek | accessdata.fda.gov |
| November 29, 1994 | K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | DYW | Substantially Equivalent | Unitek Corp. | accessdata.fda.gov |
| May 29, 1991 | K911271 | ADHESIVE PRECOATED BRACKETS | DYH | Substantially Equivalent | Unitek Corp. | accessdata.fda.gov |
| March 31, 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | Unitek Corp. | accessdata.fda.gov |
| January 12, 1982 | K813180 | SCOTCHBOND DENTAL ADHESIVE | KLE | Substantially Equivalent | 3M Company | accessdata.fda.gov |
Compare with other makers
- All makers of Setter, Band, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Bracket, Plastic, Orthodontic
- All makers of Wax, Dental, Intraoral
- All makers of Bracket, Ceramic, Orthodontic
Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.