Solid Cap IMPC100

GUDID 08806388221813

Intermezzo Ø3.5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388221813
• NIH Device Record Key: e2d1f4b8-77c5-4cea-9d2b-bce35dfb9fa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solid Cap
• Version Model Number: IMPC100
• Catalog Number: IMPC100
• 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	08806388221813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051018

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388221813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-25

On-Brand Devices [Solid Cap]

• 08806388223459: ExFeel Internal P=7
• 08806388223411: ExFeel Internal P=5.5
• 08806388223374: ExFeel Internal P=4
• 08806388221813: Intermezzo Ø3.5