S.H.A Screw AROHAS1603

GUDID 08809728993937

BLUEDIAMOND Implant System M1.6/ L=3

Megagen Implant Co. Ltd

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809728993937
• NIH Device Record Key: e3fabc65-87e2-4a23-96da-f5d7e35d72b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S.H.A Screw
• Version Model Number: AROHAS1603
• Catalog Number: AROHAS1603
• 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	08809728993937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210826

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [S.H.A Screw]

• 08809728993357: AnyOne Internal & ST Implant System M2/ L=3
• 08809728993340: AnyOne Internal M2/ H=2
• 08809728993968: BLUEDIAMOND Implant System M1.6/ L=7
• 08809728993951: BLUEDIAMOND Implant System M1.6/ L=5
• 08809728993944: BLUEDIAMOND Implant System M1.6/ L=4
• 08809728993937: BLUEDIAMOND Implant System M1.6/ L=3
• 08809728993920: BLUEDIAMOND Implant System M1.6/ L=2
• 08809728993388: AnyOne Internal & ST Implant System M2/ L=7
• 08809728993371: AnyOne Internal & ST Implant System M2/ L=5
• 08809728993364: AnyOne Internal & ST Implant System M2/ L=4
• 08809728993913: XPEED AnyRidge Internal Implant System M1.8/ L=5
• 08809728993906: XPEED AnyRidge Internal Implant System M1.8/ L=4
• 08809728993890: XPEED AnyRidge Internal Implant System M1.8/ L=3
• 08809728993883: XPEED AnyRidge Internal Implant System M1.8/ L=2
• 08806388299829: XPEED AnyRidge Internal Implant System M1.8/ L=7
• 08809708751182: BLUEDIAMOND Implant System M1.6/ H=7
• 08809708751175: BLUEDIAMOND Implant System M1.6/ H=5
• 08809708751168: BLUEDIAMOND Implant System M1.6/ H=4
• 08806388299775: XPEED AnyRidge Internal Implant System M1.8/ H=7
• 08806388299768: XPEED AnyRidge Internal Implant System M1.8/ H=5
• 08806388299751: XPEED AnyRidge Internal Implant System M1.8/ H=4
• 08806388287260: AnyOne Internal & ST Implant System M2/ H=5
• 08806388286485: AnyOne Internal & ST Implant System M2/ H=4
• 08806388252916: AnyOne Internal & ST Implant System M2/ H=7
• 08809931184030: ARi ExCon Implant System
• 08809931184023: ARi ExCon Implant System
• 08809931184016: ARi ExCon Implant System
• 08809931184009: ARi ExCon Implant System