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DEVICE DETAILS

NAME OF DEVICEEXTRAORAL ORTHODONTIC HEADGEAR
ESTABLISHMENT NAMEOSSTEM MALAYSIA SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGMD36787875018A
BRAND NAMEFACE MASK
MEDICAL DEVICE CATEGORYDENTAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe FACEMASK series is orthodontic headgear. These headgears will be used for a complete orthodontic treatment. The series is fixed to the patient's neck or head by the band and holds patient's chin line comfortably by ergonomic design. The FACEMASK series has Air Vents to prevent humidity and release heat.
DEVICE INTENDED PURPOSEThis device is used for orthodontic treatment and supports the patient's forehead and jaw to align the teeth. When the upper jaw grows less than the lower jaw and the lower teeth cover the upper teeth (opposite bite), or when the lower jaw protrudes from the upper jaw (squeezing jaw), this is a device to improve the growth of the upper and lower jaws by using the growth of the children's jaws.
VALIDITY DATE OF REGISTRATION26/11/2023 - 25/11/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Orthodontic Headgear_FACEMASK801-71
2Orthodontic Headgear_FACEMASK801-72
3Orthodontic Headgear_FACEMASK801-73
4Orthodontic Headgear_FACEMASK801-74
5Orthodontic Headgear_BK Mask801-76
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