Manufacturer registered with FDA
MPL Manufacturing Inc.
Tecate, CA, United States. Lists 8 dental device types with FDA across 2 registered establishments.
- Device types listed
- 8
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 2Mexico
Devices listed with FDA
What MPL Manufacturing Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | — | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2023 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | — | 2021 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Metal Band | 2017 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | — | 2023 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | — | 2017 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Metal Bracket | 2017 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2018 |
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
MPL Manufacturing Inc. 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: Orthodontic Design and Production, Inc. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Dec 2013 | K132368 | VAPOR CERAMIC BRACKET | Orthodontic Design and Production, Inc. | NJM Orthodontic Ceramic Bracket |
| 21 Nov 1997 | K973776 | REFLECTIONS | Cdb Corporation | DYW Orthodontic Plastic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTOMPL SA DE CVFDA reg. 3027157163 | Tecate Baja California, Mexico | Contract manufacturer, Repacker / relabeler |
| ORTOTEC DE BC MX SA DE CVFDA reg. 3011788941 | Tecate Baja California, Mexico | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Ortotec de BC MX S.A. de CV · Ortompl S.A. de CV
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054003). 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.