Morales Plus Protraction Face Mask

GUDID D864PLUS0

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.

Ortosim, S.A. de C.V.

Orthodontic extraoral headgear

• Primary Device ID: D864PLUS0
• NIH Device Record Key: dd484df1-dfb5-4977-854f-d9b71d7aebd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Morales Plus Protraction Face Mask
• Version Model Number: Plus
• Company DUNS: 821322146
• Company Name: Ortosim, S.A. de C.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D864PLUS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032392

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-16

Devices Manufactured by Ortosim, S.A. de C.V.

• D864ECO0 - Morales Eco Protraction Face Mask: 2018-07-06 The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward an
• D864ECOTROPIC0 - Morales Ecotropic Protraction Face Mask: 2018-07-06 The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward an
• D864MINI0 - Morales Mini Protraction Face Mask: 2018-07-06 The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward an
• D864PLUS0 - Morales Plus Protraction Face Mask: 2018-07-06The 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.
• D864PLUS0 - Morales Plus Protraction Face Mask: 2018-07-06 The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward an