Manufacturer registered with FDA
Calibaja Manufacturing, S.A. de C.V.
MEXICALI, Mexico. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Mexico
Devices listed with FDA
What Calibaja Manufacturing, S.A. de C.V. 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 Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2002 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | — | 2016 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2002 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2016 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | — | 2002 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 2002 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | — | 2015 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | — | 2002 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2007 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | 311xlc317 Orthochair | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CALIBAJA MANUFACTURING, S.A. DE C.V.FDA reg. 3003678542 | MEXICALI Baja California, Mexico | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9049944). 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.