Gold Abutment EXIGA100T

GUDID 08806388215409

Exfeel Internal Non-Octa

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388215409
• NIH Device Record Key: 08b783de-3517-4253-930a-534c41360b0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Abutment
• Version Model Number: EXIGA100
• Catalog Number: EXIGA100T
• 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	08806388215409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210161

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

[08806388215409]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [Gold Abutment]

• 08806388241477: Rescue External Hex/ Widecone
• 08806388240449: ExFeel External Hex/ Wide
• 08806388240432: ExFeel External Non-Hex/ Wide
• 08806388236985: ExFeel External Hex/ Small
• 08806388236978: ExFeel External Non-Hex/ Small
• 08806388234110: ExFeel External Hex/ Regular
• 08806388234103: ExFeel External Non-Hex/ Regular
• 08806388233267: ExFeel External C=2
• 08806388233250: ExFeel External C=1
• 08806388233243: Rescue External Ø6/ Hex
• 08806388233236: Rescue External Ø6/ Non-Hex
• 08806388232475: ExFeel External Hex
• 08806388232468: ExFeel External Non-Hex
• 08806388225149: Rescue External Ø5/ Hex
• 08806388225132: Rescue External Ø5/ Non-Hex
• 08806388222094: ExFeel Internal Octa
• 08806388222087: ExFeel Internal Non-Octa
• 08806388219650: AnyOne Internal Ø4.5/ L=12/ Non-Hex
• 08806388219643: AnyOne Internal Ø4.5/ L=12/ Hex
• 08806388214976: EZ Plus Internal Trip/ Small
• 08806388214969: EZ Plus Internal Non-Trip/ Small
• 08806388208975: Rescue Internal Trip
• 08806388208968: Rescue Internal Non-Trip
• 08806388207220: EZ Plus Internal Trip
• 08806388207206: EZ Plus Internal Non-Hex
• 08806388215416: Exfeel Internal Octa
• 08806388215409: Exfeel Internal Non-Octa
• 08809708752349: IOGO100