Meg-Ball Abutment MBAROR10

GUDID 08806388273300

C=1/ RC

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388273300
• NIH Device Record Key: 5fd5661a-957b-4f71-8229-08cfa6be61e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meg-Ball Abutment
• Version Model Number: MBAROR10
• Catalog Number: MBAROR10
• 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	08806388273300 [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

[08806388273300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-14
• Device Publish Date: 2020-04-06

On-Brand Devices [Meg-Ball Abutment]

• 08806388273423: C=6
• 08806388273416: C=5
• 08806388273409: C=4
• 08806388273393: C=3
• 08806388273386: C=2
• 08806388273379: C=1
• 08806388273362: C=0
• 08806388273355: C=6/ RC
• 08806388273348: C=5/ RC
• 08806388273331: C=4/ RC
• 08806388273324: C=3/ RC
• 08806388273317: C=2/ RC
• 08806388273300: C=1/ RC
• 08806388273294: C=0/ RC
• 08806388273287: C=6/ NC
• 08806388273270: C=5/ NC
• 08806388273263: C=4/ NC
• 08806388273256: C=3/ NC
• 08806388273249: C=2/ NC
• 08806388273232: C=1/ NC
• 08806388273225: C=0/ NC
• 08806388273218: C=6
• 08806388273201: C=5
• 08806388273195: C=4
• 08806388273188: C=3
• 08806388273171: C=2
• 08806388273164: C=1
• 08806388273157: C=0
• 08806388273140: C=6
• 08806388273133: C=5
• 08806388273126: C=4
• 08806388273119: C=3
• 08806388273102: C=2
• 08806388273096: C=1
• 08806388273089: C=0
• 08806388297399: AnyOne OneStage C=7
• 08809728994125: MBMI70
• 08809728994118: MBMI60
• 08809728994101: MBMI50
• 08809728994095: MBMI40
• 08809728994088: MBMI30
• 08809728994071: MBMI20
• 08809728994064: MBMI10
• 08806388297382: MBAROR70
• 08806388297375: MBARON70
• 08806388297368: MBAR70
• 08806388297351: MBAO70