Abutment Screw STABSS

GUDID 08806388249084

M2

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388249084
• NIH Device Record Key: 87442898-6a3e-4502-b078-6811ac7949d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment Screw
• Version Model Number: STABSS
• Catalog Number: STABSS
• 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	08806388249084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192347

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388249084]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-03
• Device Publish Date: 2019-12-26

On-Brand Devices [Abutment Screw]

• 08806388238378: Rescue External M2/ Hex
• 08806388238361: ExFeel External M1.4/ Hex
• 08806388234332: ExFeel External M1.6/ Small
• 08806388231379: ExFeel External M2/ Regular, Wide
• 08806388226412: MiNi Internal M1.4
• 08806388226405: MiNi Internal M1.4
• 08806388225392: Rescue External M2.5
• 08806388222339: ExFeel Internal M2
• 08806388214754: EZ Plus Internal M1.6/ Small
• 08806388211289: AnyOne Internal M2
• 08806388208814: Rescue Internal M2.5/ Short
• 08806388207077: EZ Plus Internal M2/ Regular
• 08806388260508: M1.6
• 08806388249091: M2
• 08806388249084: M2
• 08806388249077: M1.6
• 08806388249060: M1.6
• 08809822765508: BLUEDIAMOND IMPLANT System M1.6/ Long
• 08809822765492: BLUEDIAMOND IMPLANT System M1.6/ Long
• 08809708754749: AnyOne Internal & ST Implant System M2
• 08809708754732: ST Internal Implant System M2
• 08809708754725: BLUEDIAMOND Implant System M1.6
• 08809708752202: ST Internal Implant System M1.6
• 08809708752196: ExFeel Internal & EZ External System M1.6/ Small
• 08809708752189: ExFeel Internal & EZ External System M2/ Regular, Wide
• 08809708752141: MiNi Internal Implant System M1.4
• 08809708752134: BLUEDIAMOND Implant System M1.6
• 08806388229680: MUAS20
• 08806388220335: IAAS600
• 08809854028930: ARi ExCon Implant System
• 08809822765430: ARi ExCon Implant System
• 08809985653964: AnyRidge
• 08809985653957: AnyRidge
• 08809985653940: AnyRidge
• 08809985652509: AnyRidge
• 08809985652493: AnyRidge
• 08809985652486: AnyRidge