s-Clean MOA Abutment

GUDID 08806169110640

Dental Implant System / s-Clean MOA Abutment D6.5mm, Cuff3.3mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169110640
• NIH Device Record Key: cb9a6f04-18ff-4f76-8f79-93266a17b3db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean MOA Abutment
• Version Model Number: DSMA65357
• 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: 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	08806169110640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

[08806169110640]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-08-26

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• 08806169110572: Dental Implant System / s-Clean MOA Abutment D6.5mm, Cuff1.8mm
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• 08806169110534: Dental Implant System / s-Clean MOA Abutment D5.5mm, Cuff3.3mm
• 08806169110527: Dental Implant System / s-Clean MOA Abutment D5.5mm, Cuff2.8mm
• 08806169110510: Dental Implant System / s-Clean MOA Abutment D5.5mm, Cuff2.8mm
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