Healing Abutment AROHMR80103NT

GUDID 08806388293438

BLUEDIAMOND Implant System M/ M8/ L10/ H=3/ RC/ Non-Octa

Megagen Implant Co. Ltd

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806388293438
• NIH Device Record Key: 17e76222-e92f-4515-a785-09e65a9b1514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Abutment
• Version Model Number: AROHMR80103N
• Catalog Number: AROHMR80103NT
• 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: 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	08806388293438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210826

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [Healing Abutment]

• 08806388241330: ExFeel External Ø7/ H=7/ Wide/ T-Type
• 08806388241316: ExFeel External Ø7/ H=5/ Wide/ T-Type
• 08806388241293: ExFeel External Ø7/ H=4/ Wide/ T-Type
• 08806388241279: ExFeel External Ø7/ H=3/ Wide/ T-Type
• 08806388241255: ExFeel External Ø7/ H=2/ Wide/ T-Type
• 08806388241231: ExFeel External Ø6/ H=7/ Wide
• 08806388241217: ExFeel External Ø6/ H=5/ Wide
• 08806388241194: ExFeel External Ø6/ H=4/ Wide
• 08806388241170: ExFeel External Ø6/ H=3/ Wide
• 08806388241156: ExFeel External Ø6/ H=2/ Wide
• 08806388235179: ExFeel External Ø4/ H=5/ Small
• 08806388235155: ExFeel External Ø4/ H=4/ Small
• 08806388235131: ExFeel External Ø4/ H=3/ Small
• 08806388235117: ExFeel External Ø4/ H=2/ Small
• 08806388231706: ExFeel External Ø6/ H=7/ Regular
• 08806388231683: ExFeel External Ø6/ H=5/ Regular
• 08806388231669: ExFeel External Ø6/ H=4/ Regular
• 08806388231645: ExFeel External Ø6/ H=3/ Regular
• 08806388231621: ExFeel External Ø6/ H=2/ Regular
• 08806388231607: ExFeel External Ø5/ H=7/ Regular
• 08806388231584: ExFeel External Ø5/ H=5/ Regular
• 08806388231560: ExFeel External Ø5/ H=4/ Regular
• 08806388231546: ExFeel External Ø5/ H=3/ Regular
• 08806388231522: ExFeel External Ø5/ H=2/ Regular
• 08806388226801: MiNi Internal Ø3.5/ H=4.5
• 08806388226795: MiNi Internal Ø3.5/ H=3.5
• 08806388226788: MiNi Internal Ø3.5/ H=2.5
• 08806388226771: MiNi Internal Ø3.5/ H=1.5
• 08806388226764: MiNi Internal Ø3.5/ H=1
• 08806388226757: MiNi Internal Ø3/ H=4.5
• 08806388226740: MiNi Internal Ø3/ H=3.5
• 08806388226733: MiNi Internal Ø3/ H=2.5
• 08806388226726: MiNi Internal Ø3/ H=1.5
• 08806388226719: MiNi Internal Ø3/ H=1
• 08806388225484: Rescue External Ø8/ H=6
• 08806388225477: Rescue External Ø8/ H=4
• 08806388225460: Rescue External Ø6/ H=7
• 08806388225453: Rescue External Ø6/ H=5
• 08806388225446: Rescue External Ø6/ H=4
• 08806388225439: Rescue External Ø6/ H=3
• 08806388225422: Rescue External Ø6/ H=2
• 08806388225415: Rescue External Ø10/ H=6
• 08806388225408: Rescue External Ø10/ H=4
• 08806388222391: ExFeel Internal Ø5.5/ H=4
• 08806388222384: ExFeel Internal Ø5.5/ H=3
• 08806388222377: ExFeel Internal Ø5.5/ H=2
• 08806388220038: AnyOne Internal Ø9.5/ H=6
• 08806388220021: AnyOne Internal Ø9.5/ H=5
• 08806388220014: AnyOne Internal Ø9.5/ H=4
• 08806388220007: AnyOne Internal Ø8.5/ H=6