s-Clean Healing Abutment s-Line Mini

GUDID 08800053031400

Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4850)

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800053031400
• NIH Device Record Key: 9c861cd1-9942-4a32-b706-be092baf3993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Healing Abutment s-Line Mini
• Version Model Number: DSHMZ4850
• Company DUNS: 694721181
• 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	08800053031400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210080

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [s-Clean Healing Abutment s-Line Mini]

• 08800053031509: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5890)
• 08800053031493: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ587)
• 08800053031486: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5860)
• 08800053031479: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5850)
• 08800053031462: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5840)
• 08800053031455: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5830)
• 08800053031448: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ5820)
• 08800053031431: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4890)
• 08800053031424: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4870)
• 08800053031417: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4860)
• 08800053031400: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4850)
• 08800053031394: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4840)
• 08800053031387: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4830)
• 08800053031370: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4820)
• 08800053031363: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4390)
• 08800053031356: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4370)
• 08800053031349: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4360)
• 08800053031332: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4350)
• 08800053031325: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4340)
• 08800053031318: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4330)
• 08800053031301: Dental Implant System / s-Clean Healing Abutment s-Line Mini (DSHMZ4320)