Flat abutment FA3535

GUDID 08806388216451

AnyOne Internal Ø3.5/ C=3.5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388216451
• NIH Device Record Key: a3f7461c-ec97-4c1c-992e-8d4cc1ed9368
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flat abutment
• Version Model Number: FA3535
• Catalog Number: FA3535
• 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	08806388216451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388216451]

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: 2015-06-23

On-Brand Devices [Flat abutment]

• 08806388216475: AnyOne Internal Ø3.5/ C=3.5
• 08806388216468: AnyOne Internal Ø3.5/ C=4.5
• 08806388216451: AnyOne Internal Ø3.5/ C=3.5
• 08806388216444: AnyOne Internal Ø3.5/ C=2.5
• 08806388216437: AnyOne Internal Ø3.5/ C=1.5