DEVICE: Ti-one 101 (04719871590966)

Device Identifier (DI) Information

Ti-one 101
HF01-304520
In Commercial Distribution

HUNG CHUN BIO-S CO., LTD.
04719871590966
GS1

1
657513573 *Terms of Use
Cover Screw Ø4.5, H 2.0mm The 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.
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Device Characteristics

MR Safe
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental implant suprastructure, temporary, single-use A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NHA Abutment, Implant, Dental, Endosseous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110425 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

53f52447-84d3-421e-b793-0074c732222c
July 06, 2018
3
November 25, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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