MORALES PROTRACTION FACEMASK
ORTOSIM, S.A. DE C.V.
ORTOSIM, S.A. DE C.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003948427 | 3003948427 | ORTOSIM, S.A. DE C.V. | 1 | N | 2026-01-01 | CONVENTO DE ACTOPAN No. 13-A TLALNEPANTLA Mexico MX 54050 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20994 | 1120824160 | K032392 | MORALES PROTRACTION FACEMASK | DZB | 2003-10-22 |
| 20994 | 2071877250 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DZB | 1 | 2003-10-22 |
PMN#
GUDID#
Morales Eco Protraction Face Mask - The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
2016-11-16
Morales Ecotropic Protraction Face Mask - The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
2017-05-26
Morales Mini Protraction Face Mask - The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
2016-11-16
Morales Plus Protraction Face Mask - The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
2016-11-16