s-Clean Healing Abutment

GUDID 08806169132987

Dental Implant System / s-Clean Healing Abutment D4.0mm X L11.4mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169132987
• NIH Device Record Key: e9a32236-52f2-49a3-b378-3ed0ebae3413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Healing Abutment
• Version Model Number: DSHS4045
• 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	08806169132987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

Moist Heat or Steam Sterilization

[08806169132987]

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: 2017-01-10

On-Brand Devices [s-Clean Healing Abutment]

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• 08806169101310: Dental Implant System / s-Clean Healing Abutment D7.0mm X L12.0mm
• 08806169101303: Dental Implant System / s-Clean Healing Abutment D7.0mm X L11.0mm
• 08806169101297: Dental Implant System / s-Clean Healing Abutment D7.0mm X L10.5mm
• 08806169101280: Dental Implant System / s-Clean Healing Abutment D7.0mm X L10.0mm
• 08806169101273: Dental Implant System / s-Clean Healing Abutment D6.5mm X L14.0mm
• 08806169101266: Dental Implant System / s-Clean Healing Abutment D6.5mm X L13.0mm
• 08806169101259: Dental Implant System / s-Clean Healing Abutment D6.5mm X L12.0mm
• 08806169101242: Dental Implant System / s-Clean Healing Abutment D6.5mm X L11.0mm
• 08806169101235: Dental Implant System / s-Clean Healing Abutment D6.5mm X L10.5mm
• 08806169101228: Dental Implant System / s-Clean Healing Abutment D6.5mm X L10.0mm
• 08806169101211: Dental Implant System / s-Clean Healing Abutment D6.0mm X L14.0mm
• 08806169101204: Dental Implant System / s-Clean Healing Abutment D6.0mm X L13.0mm
• 08806169101198: Dental Implant System / s-Clean Healing Abutment D6.0mm X L12.0mm
• 08806169101181: Dental Implant System / s-Clean Healing Abutment D6.0mm X L11.0mm
• 08806169101174: Dental Implant System / s-Clean Healing Abutment D6.0mm X L10.5mm
• 08806169101167: Dental Implant System / s-Clean Healing Abutment D6.0mm X L10.0mm
• 08806169101150: Dental Implant System / s-Clean Healing Abutment D6.0mm X L9.5mm
• 08806169101143: Dental Implant System / s-Clean Healing Abutment D5.5mm X L14.0mm
• 08806169101136: Dental Implant System / s-Clean Healing Abutment D5.5mm X L13.0mm
• 08806169101129: Dental Implant System / s-Clean Healing Abutment D5.5mm X L12.0mm
• 08806169101112: Dental Implant System / s-Clean Healing Abutment D5.5mm X L11.0mm
• 08806169101105: Dental Implant System / s-Clean Healing Abutment D5.5mm X L10.5mm
• 08806169101099: Dental Implant System / s-Clean Healing Abutment D5.5mm X L10.0mm
• 08806169101082: Dental Implant System / s-Clean Healing Abutment D5.5mm X L9.5mm
• 08806169101075: Dental Implant System / s-Clean Healing Abutment D5.0mm X L14.0mm
• 08806169101068: Dental Implant System / s-Clean Healing Abutment D5.0mm X L13.0mm
• 08806169101051: Dental Implant System / s-Clean Healing Abutment D5.0mm X L12.0mm
• 08806169101044: Dental Implant System / s-Clean Healing Abutment D5.0mm X L11.0mm
• 08806169101037: Dental Implant System / s-Clean Healing Abutment D5.0mm X L10.5mm
• 08806169101020: Dental Implant System / s-Clean Healing Abutment D5.0mm X L10.0mm
• 08806169101013: Dental Implant System / s-Clean Healing Abutment D5.0mm X L9.5mm
• 08806169101006: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L14.0mm
• 08806169100993: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L13.0mm
• 08806169100986: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L12.0mm
• 08806169100979: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L11.0mm
• 08806169100962: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L10.5mm
• 08806169100955: Dental Implant Sysem / s-Clean Healing Abutment D4.5mm X L10.0mm
• 08806169105912: Dental Implant System / s-Clean Healing Abutment D6.5mm X L13.5mm
• 08806169105905: Dental Implant System / s-Clean Healing Abutment D6.5mm X L12.5mm
• 08806169105899: Dental Implant System / s-Clean Healing Abutment D6.5mm X L11.5mm
• 08806169105882: Dental Implant System / s-Clean Healing Abutment D6.5mm X L9.5mm
• 08806169105875: Dental Implant System / s-Clean Healing Abutment D6.0mm X L13.5mm
• 08806169105868: Dental Implant System / s-Clean Healing Abutment D6.0mm X L12.5mm
• 08806169105851: Dental Implant System / s-Clean Healing Abutment D6.0mm X L11.5mm
• 08806169105844: Dental Implant System / s-Clean Healing Abutment D5.5mm X L13.5mm
• 08806169105837: Dental Implant System / s-Clean Healing Abutment D5.5mm X L12.5mm
• 08806169105820: Dental Implant System / s-Clean Healing Abutment D5.5mm X L11.5mm