Meg-Rhein Overdenture ARODN02P

GUDID 08806388262700

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388262700
• NIH Device Record Key: a32df081-d6d0-4ce2-8359-53addbda2aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meg-Rhein Overdenture
• Version Model Number: ARODN02P
• Catalog Number: ARODN02P
• 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	08806388262700 [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

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

[08806388262700]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Meg-Rhein Overdenture]

• 08806388271412: MDR05PA
• 08806388271399: MDR03PA
• 08806388271382: MDR02PA
• 08806388271375: MDR01PA
• 08806388271368: MDR00PA
• 08806388269310: ADR06P
• 08806388269303: ADR05P
• 08806388269297: ADR02P
• 08806388269280: ADR00P
• 08806388268276: ADR01P
• 08806388261895: ADR04P
• 08806388256846: ADR03P
• 08806388262847: ARODN02PA
• 08806388262830: ARODN01PA
• 08806388262823: ARODN00PA
• 08806388262717: ARODN03P
• 08806388262700: ARODN02P
• 08806388262694: ARODN01P
• 08806388262687: ARODN00P
• 08806388271351: DR06PA
• 08806388271344: DR05PA
• 08806388271337: DR04PA
• 08806388271320: DR00PA
• 08806388271184: DR01PA
• 08806388268290: DR03PA
• 08806388268283: DR02PA
• 08806388262953: ARODR06PA
• 08806388262946: ARODR05PA
• 08806388262939: ARODR04PA
• 08806388262922: ARODR03PA
• 08806388262915: ARODR02PA
• 08806388262908: ARODR01PA
• 08806388262892: ARODR00PA
• 08806388262885: ARODN06PA
• 08806388262878: ARODN05PA
• 08806388262861: ARODN04PA
• 08806388262854: ARODN03PA
• 08806388262816: ARODR06P
• 08806388262809: ARODR05P
• 08806388262793: ARODR04P
• 08806388262786: ARODR03P
• 08806388262779: ARODR02P
• 08806388262762: ARODR01P
• 08806388262755: ARODR00P
• 08806388262748: ARODN06P
• 08806388262731: ARODN05P
• 08806388262724: ARODN04P
• 08806388256259: EDW06PA
• 08806388256242: EDW04PA