FDA.reportPublic FDA data

Morales Plus Protraction Face Mask

Primary DI
D864PLUS0
Brand
Morales Plus Protraction Face Mask
Company
Ortosim, S.A. de C.V.
Model
Plus
Device description
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.
Published
2016-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032392000MORALES PROTRACTION FACEMASKOrtosim, S.A. DE C.V.2003-10-22DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D864PLUS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
821322146
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D864ECO0Morales Eco Protraction Face MaskEco2016-11-16
D864ECOTROPIC0Morales Ecotropic Protraction Face MaskEcotropic2017-05-26
D864MINI0Morales Mini Protraction Face MaskMini2016-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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