Ball Abutment EIBR06

GUDID 08806388214006

ExFeel External C=6

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388214006
• NIH Device Record Key: ee235623-f687-4d46-a999-ca0ce4fb4dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball Abutment
• Version Model Number: EIBR06
• Catalog Number: EIBR06
• 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	08806388214006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101890

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388214006]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-24

On-Brand Devices [Ball Abutment]

• 08806388232611: Rescue External C=6
• 08806388232604: Rescue External C=4
• 08806388232598: Rescue External C=2
• 08806388232581: Rescue External C=0
• 08806388232444: Rescue External Ø6/ C=6
• 08806388232437: Rescue External Ø6/ C=4
• 08806388232420: Rescue External Ø6/ C=2
• 08806388232413: Rescue External Ø5/ C=6
• 08806388232406: Rescue External Ø5/ C=4
• 08806388232390: Rescue External Ø5/ C=2
• 08806388214839: EZ Plus Internal C=6/ Small
• 08806388214822: EZ Plus Internal C=4/ Small
• 08806388214815: EZ Plus Internal C=2/ Small
• 08806388214808: EZ Plus Internal C=0/ Small
• 08806388214792: EZ Plus Internal C=6
• 08806388214785: EZ Plus Internal C=4
• 08806388214778: EZ Plus Internal C=2
• 08806388214761: EZ Plus Internal C=0
• 08806388214006: ExFeel External C=6
• 08806388213993: ExFeel External C=4
• 08806388213986: ExFeel External C=2
• 08806388213979: ExFeel External C=0
• 08806388213009: ExFeel External C=6/ Wide
• 08806388212996: ExFeel External C=4/ Wide
• 08806388212989: ExFeel External C=2/ Wide
• 08806388212972: ExFeel External C=6/ Small
• 08806388212965: ExFeel External C=4/ Small
• 08806388212958: ExFeel External C=2/ Small
• 08806388212941: ExFeel External C=6/ Regular
• 08806388212934: ExFeel External C=4/ Regular
• 08806388212927: ExFeel External C=2/ Regular
• 08806388211371: AnyOne Internal C=5.5
• 08806388211364: AnyOne Internal C=3.5
• 08806388211357: AnyOne Internal C=1.5
• 08806388211340: AnyOne Internal C=0
• 08806388200924: AnyRidge Internal C=6
• 08806388200917: AnyRidge Internal C=4
• 08806388200900: AnyRidge Internal C=2
• 08806388200894: AnyRidge Internal C=0