Duns Number:831465641
Device Description: PROTRACTION FACE MASK (COMPLETE). The adaptability of this Protraction Face Mask allows f PROTRACTION FACE MASK (COMPLETE). The adaptability of this Protraction Face Mask allows for directional force application by adjusting the elastics engagement bar to deliver protractive force in the desired plane. Fully adjustable forehead and chin rests allow for adaptation to most patient’s anatomical structure. The angle of traction is then determined by adjusting the elastics engagement bar to deliver horizontal, upward or downward forces as necessary. Includes Allen wrench and 3 sets of pads.
Catalog Number
-
Brand Name
G&H PROTRACTION FACE MASK
Version/Model Number
PFMLG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111169
Product Code
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
409d9ff3-74c8-474d-adf1-23f5aecc84fb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 288 |