AnyRidge Octa 1 Fixture ARO4108P

GUDID 08806388257027

(C3.5) Ø4.1/ L8.5

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806388257027
• NIH Device Record Key: 797658b3-20e5-408c-8ecf-a6c850705925
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyRidge Octa 1 Fixture
• Version Model Number: ARO4108
• Catalog Number: ARO4108P
• 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	08806388257027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182448

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: 2019-11-26
• Device Publish Date: 2019-11-18

On-Brand Devices [AnyRidge Octa 1 Fixture]

• 08806388269907: (C3.8) Ø4.4/ L10.0
• 08806388269891: (C3.8) Ø4.4/ L8.5
• 08806388269884: (C3.8) Ø4.4/ L7.0
• 08806388269877: (C3.5) Ø4.1/ L18.0
• 08806388269860: (C3.5) Ø4.1/ L15.0
• 08806388269853: (C3.5) Ø4.1/ L13.0
• 08806388269846: (C3.5) Ø4.1/ L11.5
• 08806388269839: (C3.5) Ø4.1/ L10.0
• 08806388269822: (C3.5) Ø4.1/ L8.5
• 08806388269815: (C3.5) Ø4.1/ L7.0
• 08806388269808: (C3.2) Ø3.7/ L18.0
• 08806388269792: (C3.2) Ø3.7/ L15.0
• 08806388269785: (C3.2) Ø3.7/ L13.0
• 08806388269778: (C3.2) Ø3.7/ L11.5
• 08806388269761: (C3.2) Ø3.7/ L10.0
• 08806388269754: (C3.2) Ø3.7/ L8.5
• 08806388269747: (C3.2) Ø3.7/ L7.0
• 08806388269730: (C2.8) Ø3.3/ L18.0
• 08806388269723: (C2.8) Ø3.3/ L15.0
• 08806388269716: (C2.8) Ø3.3/ L13.0
• 08806388269709: (C2.8) Ø3.3/ L11.5
• 08806388269693: (C2.8) Ø3.3/ L10.0
• 08806388269686: (C2.8) Ø3.3/ L8.5
• 08806388269679: (C2.8) Ø3.3/ L7.0
• 08806388269556: (C3.8) Ø4.4/ L10.0
• 08806388269549: (C3.8) Ø4.4/ L8.5
• 08806388269532: (C3.8) Ø4.4/ L7.0
• 08806388269525: (C3.5) Ø4.1/ L18.0
• 08806388269518: (C3.5) Ø4.1/ L15.0
• 08806388269501: (C3.5) Ø4.1/ L13.0
• 08806388269495: (C3.5) Ø4.1/ L11.5
• 08806388269488: (C3.5) Ø4.1/ L10.0
• 08806388269471: (C3.5) Ø4.1/ L8.5
• 08806388269464: (C3.5) Ø4.1/ L7.0
• 08806388269457: (C3.2) Ø3.7/ L18.0
• 08806388269440: (C3.2) Ø3.7/ L15.0
• 08806388269433: (C3.2) Ø3.7/ L13.0
• 08806388269426: (C3.2) Ø3.7/ L11.5
• 08806388269419: (C3.2) Ø3.7/ L10.0
• 08806388269396: (C3.2) Ø3.7/ L7.0
• 08806388269389: (C2.8) Ø3.3/ L18.0
• 08806388269372: (C2.8) Ø3.3/ L15.0
• 08806388269365: (C2.8) Ø3.3/ L13.0
• 08806388269358: (C2.8) Ø3.3/ L11.5
• 08806388269341: (C2.8) Ø3.3/ L10.0
• 08806388269334: (C2.8) Ø3.3/ L8.5
• 08806388269327: (C2.8) Ø3.3/ L7.0
• 08806388257379: (C3.8) Ø4.4/ L8.5
• 08806388257362: (C3.8) Ø4.4/ L7.0
• 08806388257355: (C3.5) Ø4.1/ L18.0