Manufacturer registered with FDA
Xplora USA LLC
Carrollton, TX, United States. Lists 24 dental device types with FDA across 1 registered establishment.
- Device types listed
- 24
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Xplora USA LLC currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Xplora USA LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Reliance Orthodontic Products, Inc. (7), Sms Opco, LLC (1), Ortho Specialties (1), Bisco, Inc. (1), Dxm Co., Ltd. (1), Kuraray America, Inc. (1), Apex Dental Materials, Inc. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jun 2021 | K210652 | 6MS Invisible Aligner | Sms Opco, LLC | NXC Sequential Aligner |
| 12 Nov 2014 | K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | DYW Orthodontic Plastic Bracket |
| 11 Apr 2014 | K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | Bisco, Inc. | KLE Resin Tooth Bonding Agent |
| 27 Nov 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Dxm Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 20 Feb 2009 | K083051 | FLOWTAIN & FLOWTAIN LV | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 Sep 2007 | K071688 | RELIANCE S.E.P. | Reliance Orthodontic Products, Inc. | KLE Resin Tooth Bonding Agent |
| 31 Jul 2007 | K071590 | THERMA-CURE | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 2 Feb 2007 | K063593 | CLEARFIL MAJESTY FLOW | Kuraray America, Inc. | EBF Resin Tooth Shade Material |
| 1 Feb 2006 | K053103 | INTERFACE | Apex Dental Materials, Inc. | KLE Resin Tooth Bonding Agent |
| 21 Nov 1997 | K973776 | REFLECTIONS | Cdb Corporation | DYW Orthodontic Plastic Bracket |
| 8 Dec 1989 | K895523 | PHASE II ORTHODONTIC ADHESIVE | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 Dec 1989 | K895522 | LIGHT BOND PASTE W/FLUORIDE | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 18 Apr 1988 | K880790 | PORCELAIN PRIMER | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 29 Feb 1988 | K875142 | PHASE II | Reliance Orthodontic Products, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Xplora USA LLCFDA reg. 3008882689 | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089697). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.