Intermezzo Fixture IMTI1615

GUDID 08806388221875

Intermezzo Ø1.6/ L=15

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806388221875
• NIH Device Record Key: a80c5c4e-d48e-42ee-b73f-04748a7992cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intermezzo Fixture
• Version Model Number: IMTI1615
• Catalog Number: IMTI1615
• 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: true
• 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	08806388221875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051018

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-03-24
• Device Publish Date: 2015-06-25

On-Brand Devices [Intermezzo Fixture]

• 08806388222056: Intermezzo Ø3.1/ L=15
• 08806388221967: Intermezzo Ø2.5/ L=10
• 08806388221875: Intermezzo Ø1.6/ L=15
• 08806388222049: Intermezzo Ø3.1/ L=13
• 08806388222025: Intermezzo Ø3.1/ L=10
• 08806388221998: Intermezzo Ø2.5/ L=15
• 08806388221981: Intermezzo Ø2.5/ L=13