e-Clean Healing Abutment

GUDID 08806169102904

Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height4.8mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169102904
• NIH Device Record Key: d3692095-b3d5-447d-b199-ff56299e273c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-Clean Healing Abutment
• Version Model Number: DEHM440
• Company DUNS: 688204158
• Company Name: DENTIS 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: false
• 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	08806169102904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-03
• Device Publish Date: 2015-08-25

On-Brand Devices [e-Clean Healing Abutment]

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• 08806169102959: Dental Implant System / e-Clean Healing Abutment D5.0mm, Post Height4.8mm
• 08806169102942: Dental Implant System / e-Clean Healing Abutment D5.0mm, Post Height3.8mm
• 08806169102935: Dental Implant System / e-Clean Healing Abutment D5.0mm, Post Height2.8mm
• 08806169102928: Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height7.8mm
• 08806169102911: Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height5.8mm
• 08806169102904: Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height4.8mm
• 08806169102898: Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height3.8mm
• 08806169102881: Dental Implant System / e-Clean Healing Abutment D4.0mm, Post Height2.8mm