TiGEN Abutment OCTW1220.MTN

GUDID 08806388245680

Common Ø12/ L=20/ Wide

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388245680
• NIH Device Record Key: 7d2673b6-1717-4c8a-9810-8918c4bcfb4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiGEN Abutment
• Version Model Number: OCTW1220
• Catalog Number: OCTW1220.MTN
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806388245680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220562

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

[08806388245680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [TiGEN Abutment]

• 08809708759331: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core3.3
• 08809708759324: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core3.3
• 08809708759317: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core4
• 08809708759300: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core4
• 08809708759294: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core4.8
• 08809708759287: XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core4.8
• 08806388267149: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4.8
• 08806388267132: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4.8
• 08806388267125: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4
• 08806388267118: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4
• 08806388267101: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core3.3
• 08806388267095: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core3.3
• 08806388267088: Common Ø10/ L=20/ Wide/ Non-Octa
• 08806388267071: Common Ø10/ L=20/ Wide
• 08806388267064: Common Ø10/ L=20/ Regular/ Non-Octa
• 08806388267057: Common Ø10/ L=20/ Regular
• 08806388267040: Common Ø10/ L=20/ Small/ Non-Octa
• 08806388267033: Common Ø10/ L=20/ Small
• 08806388267026: AnyOne Internal & ST Implant System Ø10/ L=20/ Non-Hex
• 08806388267019: AnyOne Internal & ST Implant System Ø10/ L=20
• 08806388267002: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex
• 08806388266999: XPEED AnyRidge Internal Implant System Ø10/ L=20
• 08806388266944: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4.8
• 08806388266937: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4.8
• 08806388266920: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4
• 08806388266913: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4
• 08806388266906: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core3.3
• 08806388266890: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core3.3
• 08806388266883: Common Ø10/ L=20/ Wide/ Non-Octa
• 08806388266876: Common Ø10/ L=20/ Wide
• 08806388266869: Common Ø10/ L=20/ Regular/ Non-Octa
• 08806388266852: Common Ø10/ L=20/ Regular
• 08806388266845: Common Ø10/ L=20/ Small/ Non-Octa
• 08806388266838: Common Ø10/ L=20/ Small
• 08806388266821: AnyOne Internal & ST Implant System Ø10/ L=20/ Non-Hex
• 08806388266814: AnyOne Internal & ST Implant System Ø10/ L=20
• 08806388266807: XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex
• 08806388266791: XPEED AnyRidge Internal Implant System Ø10/ L=20
• 08806388261208: BLUEDIAMOND Implant System Ø12/ L=20/ RC
• 08806388261192: BLUEDIAMOND Implant System Ø10/ L=20/ RC
• 08806388261185: BLUEDIAMOND Implant System Ø12/ L=20/ NC
• 08806388261178: BLUEDIAMOND Implant System Ø10/ L=20/ NC
• 08806388260935: BLUEDIAMOND Implant System Ø12/ L=20/ RC
• 08806388260928: BLUEDIAMOND Implant System Ø10/ L=20/ RC
• 08806388260911: BLUEDIAMOND Implant System Ø12/ L=20/ NC
• 08806388260904: BLUEDIAMOND Implant System Ø10/ L=20/ NC
• 08806388245710: MiNi Internal Implant System Ø10/ L=20/ Non-Hex
• 08806388245703: MiNi Internal Implant System Ø10/ L=20
• 08806388245697: Common Ø12/ L=20/ Wide/ Non-Octa
• 08806388245680: Common Ø12/ L=20/ Wide