PMMA Abutment

GUDID 08809854026318

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809854026318
• NIH Device Record Key: 1cbb2cf8-e69f-4cda-a62a-6cd1160b6e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMMA Abutment
• Version Model Number: BDPAR0616BT
• 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: 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	08809854026318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234142

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

[08809854026318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [PMMA Abutment]

• 08809854026547: AOPA3016DT
• 08809854026530: AOPA3016BT
• 08809854026523: AOPA1516DT
• 08809854026516: AOPA1516BT
• 08809854026509: AOPA0616DT
• 08809854026493: AOPA0616BT
• 08809854026486: AOPA3012DT
• 08809854026479: AOPA3012BT
• 08809854026462: AOPA1512DT
• 08809854026455: AOPA1512BT
• 08809854026448: AOPA0612DT
• 08809854026431: AOPA0612BT
• 08809854026424: AOPA3008DT
• 08809854026417: AOPA3008BT
• 08809854026400: AOPA1508DT
• 08809854026394: AOPA1508BT
• 08809854026387: AOPA0608DT
• 08809854026370: AOPA0608BT
• 08809854026363: BDPAR3016DT
• 08809854026356: BDPAR3016BT
• 08809854026349: BDPAR1516DT
• 08809854026332: BDPAR1516BT
• 08809854026325: BDPAR0616DT
• 08809854026318: BDPAR0616BT
• 08809854026301: BDPAR3012DT
• 08809854026295: BDPAR3012BT
• 08809854026288: BDPAR1512DT
• 08809854026271: BDPAR1512BT
• 08809854026264: BDPAR0612DT
• 08809854026257: BDPAR0612BT
• 08809854026240: BDPAR3008DT
• 08809854026233: BDPAR3008BT
• 08809854026226: BDPAR1508DT
• 08809854026219: BDPAR1508BT
• 08809854026202: BDPAR0608DT
• 08809854026196: BDPAR0608BT
• 08809854026189: BDPAN3016DT
• 08809854026172: BDPAN3016BT
• 08809854026165: BDPAN1516DT
• 08809854026158: BDPAN1516BT
• 08809854026141: BDPAN0616DT
• 08809854026134: BDPAN0616BT
• 08809854026127: BDPAN3012DT
• 08809854026110: BDPAN3012BT
• 08809854026103: BDPAN1512DT
• 08809854026097: BDPAN1512BT
• 08809854026080: BDPAN0612DT
• 08809854026073: BDPAN0612BT
• 08809854026066: BDPAN3008DT
• 08809854026059: BDPAN3008BT