Comfort Cap AICC

GUDID 08806388275229

L=9.2

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388275229
• NIH Device Record Key: 0fa7a025-35f4-4c41-a491-2b21fef9efb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Cap
• Version Model Number: AICC
• Catalog Number: AICC
• 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	08806388275229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191127

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388275229]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-09
• Device Publish Date: 2019-11-29

On-Brand Devices [Comfort Cap]

• 08806388211623: AnyOne Internal Ø6.5/ P=7
• 08806388211616: AnyOne Internal Ø6.5/ P=5.5
• 08806388211609: AnyOne Internal Ø6.5/ P=4
• 08806388211593: AnyOne Internal Ø5.5/ P=7
• 08806388211586: AnyOne Internal Ø5.5/ P=5.5
• 08806388211579: AnyOne Internal Ø5.5/ P=4
• 08806388211562: AnyOne Internal Ø4.5/ P=7
• 08806388211555: AnyOne Internal Ø4.5/ P=5.5
• 08806388211548: AnyOne Internal Ø4.5/ P=4
• 08806388211531: AnyOne Internal Ø4/ P=7
• 08806388211524: AnyOne Internal Ø4/ P=5.5
• 08806388211517: AnyOne Internal Ø4/ P=4
• 08806388201143: AnyRidge Internal Ø7/ P=7
• 08806388201136: AnyRidge Internal Ø7/ P=5.5
• 08806388201129: AnyRidge Internal Ø7/ P=4
• 08806388201112: AnyRidge Internal Ø6/ P=7
• 08806388201105: AnyRidge Internal Ø6/ P=5.5
• 08806388201099: AnyRidge Internal Ø6/ P=4
• 08806388201082: AnyRidge Internal Ø5/ P=7
• 08806388201075: AnyRidge Internal Ø5/ P=5.5
• 08806388201068: AnyRidge Internal Ø5/ P=4
• 08806388201051: AnyRidge Internal Ø4/ P=7
• 08806388201044: AnyRidge Internal Ø4/ P=5.5
• 08806388201037: AnyRidge Internal Ø4/ P=4
• 08806388275229: L=9.2