Solid Post Cap ISPC401

GUDID 08806388223343

Exfeel Internal C=1/ P=4

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388223343
• NIH Device Record Key: 650ee054-d861-4db7-98ef-8963a3de32f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solid Post Cap
• Version Model Number: ISPC401
• Catalog Number: ISPC401
• 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	08806388223343 [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

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

Moist Heat or Steam Sterilization

[08806388223343]

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 Cap]

• 08806388223442: Exfeel Internal C=3/ P=7
• 08806388223435: Exfeel Internal C=2/ P=7
• 08806388223428: Exfeel Internal C=1/ P=7
• 08806388223404: Exfeel Internal C=3/ P=5.5
• 08806388223398: Exfeel Internal C=2/ P=5.5
• 08806388223381: Exfeel Internal C=1/ P=5.5
• 08806388223367: Exfeel Internal C=3/ P=4
• 08806388223350: Exfeel Internal C=2/ P=4
• 08806388223343: Exfeel Internal C=1/ P=4