Retentive Ring MBR5

GUDID 08806388275700

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388275700
• NIH Device Record Key: e9669091-6674-410b-8957-f482407593c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retentive Ring
• Version Model Number: MBR
• Catalog Number: MBR5
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08806388275700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192614

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

[08806388275700]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [Retentive Ring]

• 08806388260683: Ø1.5
• 08806388275717: MBR
• 08806388275700: MBR