Solid Post Abutment ISPA553P

GUDID 08806388223299

Exfeel Internal C=3/ P=5.5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388223299
• NIH Device Record Key: de38e2fe-b648-4f27-8cb8-7f99f2805bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solid Post Abutment
• Version Model Number: ISPA553
• Catalog Number: ISPA553P
• 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	08806388223299 [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

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

Moist Heat or Steam Sterilization

[08806388223299]

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 [Solid Post Abutment]

• 08806388223312: Exfeel Internal C=2/ P=7
• 08806388223329: Exfeel Internal C=3/ P=7
• 08806388223305: Exfeel Internal C=1/ P=7
• 08806388223299: Exfeel Internal C=3/ P=5.5
• 08806388223282: Exfeel Internal C=2/ P=5.5
• 08806388223275: Exfeel Internal C=1/ P=5.5
• 08806388223268: Exfeel Internal C=3/ P=4
• 08806388223251: Exfeel Internal C=2/ P=4
• 08806388223244: Exfeel Internal C=1/ P=4