Ti-one 101

GUDID 04719871591468

Abutment Ø4.5, 3.0 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be s

HUNG CHUN BIO-S CO., LTD.

Dental implant system

• Primary Device ID: 04719871591468
• NIH Device Record Key: 08563f84-24d5-41e7-b797-bd779a42c4f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti-one 101
• Version Model Number: HF01-274530
• Company DUNS: 657513573
• Company Name: HUNG CHUN BIO-S CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871591468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110425

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-25

On-Brand Devices [Ti-one 101]

• 04719871592229: Abutment Ø5.5, 20° The Ti-one 101 Dental Implant System is a device made of pure titanium meta
• 04719871592199: Abutment Ø4.5, 20° The Ti-one 101 Dental Implant System is a device made of pure titanium meta
• 04719871591512: Abutment Ø5.5, 4.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591505: Abutment Ø5.5, 3.0 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591499: Abutment Ø5.5, 1.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591482: Abutment Ø5.5, 0.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591475: Abutment Ø4.5, 4.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591468: Abutment Ø4.5, 3.0 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591451: Abutment Ø4.5, 1.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591444: Abutment Ø4.5, 0.5 mm Gingival Height The Ti-one 101 Dental Implant System is a device made of
• 04719871591390: Abutment Ø4.5, 11 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of p
• 04719871591345: Abutment Ø6.5, 10 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of p
• 04719871591338: Abutment Ø6.5, 9 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of pu
• 04719871591321: Abutment Ø5.5, 10 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of p
• 04719871591314: Abutment Ø5.5, 9 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of pu
• 04719871591307: Abutment Ø4.5, 10 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of p
• 04719871591291: Abutment Ø4.5, 9 mm Vertical Height The Ti-one 101 Dental Implant System is a device made of pu
• 04719871591109: Healing Screw Ø6.5, H 7.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591093: Healing Screw Ø6.5, H 5.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591079: Healing Screw Ø6.5, H 3.5mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591062: Healing Screw Ø5.5, H 7.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591055: Healing Screw Ø5.5, H 5.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591031: Healing Screw Ø5.5, H 3.5mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591024: Healing Screw Ø4.5, H 7.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871591017: Healing Screw Ø4.5, H 5.0mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871590997: Healing Screw Ø4.5, H 3.5mm The Ti-one 101 Dental Implant System is a device made of pure titan
• 04719871590980: Cover Screw Ø6.5, H 2.0mm The Ti-one 101 Dental Implant System is a device made of pure titaniu
• 04719871590973: Cover Screw Ø5.5, H 2.0mm The Ti-one 101 Dental Implant System is a device made of pure titaniu
• 04719871590966: Cover Screw Ø4.5, H 2.0mm The Ti-one 101 Dental Implant System is a device made of pure titaniu
• 04719871590959: Cover Screw Ø3.3, H 0mm The Ti-one 101 Dental Implant System is a device made of pure titanium
• 04719871590829: Abutment Ø6.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590812: Abutment Ø6.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590805: Abutment Ø6.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590799: Abutment Ø6.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590782: Abutment Ø6.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590775: Abutment Ø6.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590768: Abutment Ø6.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590751: Abutment Ø6.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590744: Abutment Ø5.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590737: Abutment Ø5.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590720: Abutment Ø5.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590713: Abutment Ø5.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590706: Abutment Ø5.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590690: Abutment Ø5.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590683: Abutment Ø5.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590676: Abutment Ø5.5, 4.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590669: Abutment Ø4.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590652: Abutment Ø4.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590645: Abutment Ø4.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita
• 04719871590638: Abutment Ø4.5, 6.0 mm Abt. H The Ti-one 101 Dental Implant System is a device made of pure tita