s-Clean Sole Abutment Healing Cap

GUDID 08806169131904

Dental Implant System / s-Clean Sole Abutment Healing Cap D5.5mm X L9.0mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169131904
• NIH Device Record Key: e585d8f3-50a8-4fc0-8cd2-955e6abc9177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Sole Abutment Healing Cap
• Version Model Number: DSHC557
• 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	08806169131904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171694

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

[08806169131904]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-05
• Device Publish Date: 2019-05-28

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• 08806169131829: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.0mm X L7.5mm
• 08806169131812: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.0mm X L6.0mm
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• 08806169131935: Dental Implant System / s-Clean Sole Abutment Healing Cap D6.5mm X L7.5mm
• 08806169131928: Dental Implant System / s-Clean Sole Abutment Healing Cap D6.5mm X L6.0mm
• 08806169131911: Dental Implant System / s-Clean Sole Abutment Healing Cap D6.0mm X L7.5mm
• 08806169131904: Dental Implant System / s-Clean Sole Abutment Healing Cap D5.5mm X L9.0mm
• 08806169131898: Dental Implant System / s-Clean Sole Abutment Healing Cap D5.5mm X L7.5mm
• 08806169131881: Dental Implant System / s-Clean Sole Abutment Healing Cap D5.5mm X L6.0mm
• 08806169131874: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.8mm X L7.5mm
• 08806169131867: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.5mm X L9.0mm
• 08806169131850: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.5mm X L7.5mm
• 08806169131843: Dental Implant System / s-Clean Sole Abutment Healing Cap D4.5mm X L6.0mm