Dental device manufacturers in Mexico
34 companies have an FDA-registered establishment in Mexico, across 43 sites. 30 manufacture dental devices there or own their specifications.
What they make
Dental hand instruments13Retainers, expanders & headgear8Toothbrushes7Orthodontic wires & bands6Clear aligners5Dental cements5Orthodontic brackets5Intraoral scanners4Denture cleansers & adhesives4Impression trays4Suction & evacuation units4Dental composites4Temporary crown & bridge materials4Polishing & prophylaxis4
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Ankylos Cercon Balance · Ankylos Temporary Abutment Balance · Anti rotation cementing cap for connect abutment · Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants · +253 | 148 | 2026 |
| Align Technology, Inc. | United States | Maker | iGo · iGo Plus · Invisalign ART · Invisalign Assist · +83 | 16 | 2026 |
| Sybron Dental Specialties | United States | Maker | Alert · Alert Condensable Composite · Artiste Nano Composite · Build-It FR · +553 | 203 | 2026 |
| Clemde SA DE CV | Mexico | Maker | PF Keep / Cad Cam Peek Block · Partial Flex | 2 | 2025 |
| Kline Europe GmbH | Germany | Maker | CLEAR X · K Clear | 1 | 2022 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| Manufacturera Dental Continental | Mexico | Maker | Paltop Dental Sterile Accessories · Paltop Dynamic C Dental Implant System · Paltop Narrow Implant, Paltop PCA Dental Implant system · MDC DENTAL OPERATING LIGHT · +30 | 2 | 2001 |
| Fernando Morales Garfias | Mexico | Maker | AD Protraction Facemask · Asian Profile AD Protraction Facemask · MORALES PROTRACTION FACEMASK | 1 | 2003 |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Medline Industries, LP | United States | Maker | Medline General Purpose Dental Tray · Medline patient personal hygiene kit · Medline · DuoCare · +21 | — | — |
| Candid Care Co. | United States | Maker | Candid Cheek Retractor · ScanBox Pro · Candid Aligner · Candid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008 · +18 | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | RETAINER, MOUTHGUARD, BITEGUARD · Saliva Ejector · Orthodontic Band · Wire, Orthodontic · +7 | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC · MAINTAINER, SPACE PREFORMED, ORTHODONTIC · WIRE, ORTHODONTIC · TUBE, ORTHODONTIC · +6 | — | — |
| Conamco | United States | Maker | Crushed Quartz · Medental · Medental Prophy Paste | — | — |
| O&M Halyard, Inc. | United States | Maker | Hygiene Kit · ICU Hygiene Kit · Patient Admission Kit · Patient Personal Hygiene Kit · +4 | — | — |
| Avanos Medical, Inc. | United States | Maker | DENTASWAB · KimVent Oral Care · SOFSWAB · Toothbrush · +1 | — | — |
| Celestica de Monterrey S.A. de C.V. | Mexico | Maker | JGRKNT 1MM MINI STEP DRILL · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles Multi Pack · 1mm JuggerKnot Mini 3-0 w/ Tapered Needles · +1 | — | — |
| Vago International Manufacturing SA DE CV | Mexico | Maker | Gishy Goo · Umbrella Cheek Retractor · OMNI-MATRIX ORIGINAL WINGED; ORIGNAL WINGLESS; SECTIONAL; WINGES; WINGLESS · Floss, Dental · +1 | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | 311xlc · 317 Orthochair | — | — |
| DEGASA S.A. de C.V. | Mexico | Maker | PROTEC COTTON BALLS · PROTEC COTTON, ROLL | — | — |
| MPL Manufacturing Inc. | United States | Maker | Metal Band · Metal Bracket | — | — |
| SunMed Group Holdings, LLC dba AirLife | United States | Maker | TOOTHBRUSH, MANUAL · Patient personal hygiene kit | — | — |
| Viant Medical, LLC | United States | Maker | Align Technology · Invisalign Cheek Retractor | — | — |
| Iimed Medical Mexicana S. de R.L. de C.V. | Mexico | Maker | SUB1 TEMP MAX 2.64 | — | — |
| Laboratorios Clinic, S.A. de C.V. | Mexico | Maker | Clinic | — | — |
| Yamada Vistamex S.A. de C.V. | Mexico | Maker | Braun GmbH (Oral-B) | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Seacomp Displays | Mexico | Maker | — | — | — |
| Sion Biotext Medical Ltd | Israel | Maker | — | — | — |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Mexico | Maker | — | — | — |
| GC America Inc. | United States | Maker | BULK FujiCEM(AutoCompatible) · CAVITRON · Ceramic Primer · Ceramic Primer II · +365 | 137 | 2026 |
| Sotera Health LLC | United States | Maker | Atlas Implant Packs · Celsite® Discreet STL201H · CERTAIN® FLAT IMPLANT COVER SCREW · CERTAIN® IMPLANT HEADLESS COVER SCREW · +951 | — | — |
| Centerpiece Holdings LLC | United States | Contract sterilizer | BIOMET SPORTS MEDICINE | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026