HUNG CHUN BIO-S CO., LTD.

Address:No.12, Luke 1st Rd., Luzhu Dist.,Kaohsiung City,TW

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

Clear

Ti-one 101 - 04719871590010 Catalog Number :

Device Description : Dental Implant Ø3.5, 8 mm LengthThe Ti-one 101 Dental Implant System is a device Dental Implant Ø3.5, 8 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590027 Catalog Number :

Device Description : Dental Implant Ø3.5, 9.5 mm LengthThe Ti-one 101 Dental Implant System is a devi Dental Implant Ø3.5, 9.5 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590034 Catalog Number :

Device Description : Dental Implant Ø3.5, 11 mm LengthThe Ti-one 101 Dental Implant System is a devic Dental Implant Ø3.5, 11 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590041 Catalog Number :

Device Description : Dental Implant Ø3.5, 14 mm LengthThe Ti-one 101 Dental Implant System is a devic Dental Implant Ø3.5, 14 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590058 Catalog Number :

Device Description : Dental Implant Ø4.0, 8 mm LengthThe Ti-one 101 Dental Implant System is a device Dental Implant Ø4.0, 8 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590065 Catalog Number :

Device Description : Dental Implant Ø4.0, 9.5 mm LengthThe Ti-one 101 Dental Implant System is a devi Dental Implant Ø4.0, 9.5 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590072 Catalog Number :

Device Description : Dental Implant Ø4.0, 11 mm LengthThe Ti-one 101 Dental Implant System is a devic Dental Implant Ø4.0, 11 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590089 Catalog Number :

Device Description : Dental Implant Ø4.0, 14 mm LengthThe Ti-one 101 Dental Implant System is a devic Dental Implant Ø4.0, 14 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590096 Catalog Number :

Device Description : Dental Implant Ø4.5, 7 mm LengthThe Ti-one 101 Dental Implant System is a device Dental Implant Ø4.5, 7 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Ti-one 101 - 04719871590102 Catalog Number :

Device Description : Dental Implant Ø4.5, 8 mm LengthThe Ti-one 101 Dental Implant System is a device Dental Implant Ø4.5, 8 mm LengthThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Device Class : 2

Duns Number: 657513573

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

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