FDA.reportPublic FDA data

Ti-one 101

Primary DI
04719871590997
Brand
Ti-one 101
Company
HUNG CHUN BIO-S CO., LTD.
Model
HF01-312035
Device description
Healing Screw Ø4.5, H 3.5mmThe 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.
Published
2015-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110425000HC-BIOS DENTAL IMPLANTHung Chun Bio-S Co., Ltd.2012-07-27DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871590997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871590997047198715909974719871590997

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657513573
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871590959Ti-one 101HF01-3033002015-11-25
04719871590966Ti-one 101HF01-3045202015-11-25
04719871590973Ti-one 101HF01-3055202015-11-25
04719871590980Ti-one 101HF01-3065202015-11-25
04719871591017Ti-one 101HF01-3130502015-11-25
04719871591024Ti-one 101HF01-3140702015-11-25
04719871591031Ti-one 101HF01-3220352015-11-25
04719871591055Ti-one 101HF01-3230502015-11-25
04719871591062Ti-one 101HF01-3240702015-11-25
04719871591079Ti-one 101HF01-3320352015-11-25
04719871591093Ti-one 101HF01-3330502015-11-25
04719871591109Ti-one 101HF01-3340702015-11-25
04719871590010Ti-one 101HF01-1035082015-11-24
04719871590027Ti-one 101HF01-1035952015-11-24
04719871590034Ti-one 101HF01-1035112015-11-24
04719871590041Ti-one 101HF01-1035142015-11-24
04719871590058Ti-one 101HF01-1040082015-11-24
04719871590065Ti-one 101HF01-1040952015-11-24
04719871590072Ti-one 101HF01-1040112015-11-24
04719871590089Ti-one 101HF01-1040142015-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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