s-Clean SQ-SL Implant System Mini

GUDID 08800053023832

Dental Implant System / s-Clean SQ-SL Fixture Mini (DSSFM3510)

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800053023832
• NIH Device Record Key: 490a1107-5ca1-4699-a423-8962cf279343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SQ-SL Implant System Mini
• Version Model Number: DSSFM3510
• 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	08800053023832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202773

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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 SQ-SL Implant System Mini]

• 08800053023863: Dental Implant System / s-Clean SQ-SL Fixture Mini (DSSFM4010)
• 08800053023849: Dental Implant System / s-Clean SQ-SL Fixture Mini (DSSFM3512)
• 08800053023832: Dental Implant System / s-Clean SQ-SL Fixture Mini (DSSFM3510)