Advanced Intermezzo Fixture AIF25310

GUDID 08806388274536

(C2.0) Ø2.5/ L10.0 C.H3.0

Megagen Implant Co. Ltd

Screw endosteal dental implant, one-piece

• Primary Device ID: 08806388274536
• NIH Device Record Key: 5786a10c-d1d0-422b-bc4d-2ff3313dd30c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Intermezzo Fixture
• Version Model Number: AIF25310
• Catalog Number: AIF25310
• 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	08806388274536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191127

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

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 [Advanced Intermezzo Fixture]

• 08806388274659: (C2.3) Ø3.0/ L13.0 C.H3.0
• 08806388274642: (C2.3) Ø3.0/ L11.5 C.H3.0
• 08806388274635: (C2.3) Ø3.0/ L10.0 C.H3.0
• 08806388274628: (C2.3) Ø3.0/ L8.5 C.H3.0
• 08806388274611: (C2.3) Ø3.0/ L7.0 C.H3.0
• 08806388274604: (C2.3) Ø3.0/ L13.0 C.H2.0
• 08806388274581: (C2.3) Ø3.0/ L10.0 C.H2.0
• 08806388274574: (C2.3) Ø3.0/ L8.5 C.H2.0
• 08806388274567: (C2.3) Ø3.0/ L7.0 C.H2.0
• 08806388274550: (C2.0) Ø2.5/ L13.0 C.H3.0
• 08806388274543: (C2.0) Ø2.5/ L11.5 C.H3.0
• 08806388274536: (C2.0) Ø2.5/ L10.0 C.H3.0
• 08806388274529: (C2.0) Ø2.5/ L8.5 C.H3.0
• 08806388274512: (C2.0) Ø2.5/ L7.0 C.H3.0
• 08806388274505: (C2.0) Ø2.5/ L13.0 C.H2.0
• 08806388274499: (C2.0) Ø2.5/ L11.5 C.H2.0
• 08806388274482: (C2.0) Ø2.5/ L10.0 C.H2.0
• 08806388274475: (C2.0) Ø2.5/ L8.5 C.H2.0
• 08806388274468: (C2.0) Ø2.5/ L7.0 C.H2.0
• 08806388274451: (C1.7) Ø2.0/ L13.0 C.H3.0
• 08806388274444: (C1.7) Ø2.0/ L11.5 C.H3.0
• 08806388274437: (C1.7) Ø2.0/ L10.0 C.H3.0
• 08806388274420: (C1.7) Ø2.0/ L8.5 C.H3.0
• 08806388274413: (C1.7) Ø2.0/ L7.0 C.H3.0
• 08806388274406: (C1.7) Ø2.0/ L13.0 C.H2.0
• 08806388274390: (C1.7) Ø2.0/ L11.5 C.H2.0
• 08806388274383: (C1.7) Ø2.0/ L10.0 C.H2.0
• 08806388274376: (C1.7) Ø2.0/ L8.5 C.H2.0
• 08806388274369: (C1.7) Ø2.0/ L7.0 C.H2.0