s-Clean SQ-SL Fixture

GUDID 08800053022415

s-Clean SQ-SL Fixture / DSSFR5512

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08800053022415
• NIH Device Record Key: 330cf389-0491-4334-b995-7a949b6dbfa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SQ-SL Fixture
• Version Model Number: DSSFR5512
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800053022415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210132

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: 2021-03-10
• Device Publish Date: 2021-03-02

On-Brand Devices [s-Clean SQ-SL Fixture]

• 08800053022477: s-Clean SQ-SL Fixture / DSSFR5514S
• 08800053022460: s-Clean SQ-SL Fixture / DSSFR5512S
• 08800053022453: s-Clean SQ-SL Fixture / DSSFR5510S
• 08800053022446: s-Clean SQ-SL Fixture / DSSFR5508S
• 08800053022439: s-Clean SQ-SL Fixture / DSSFR5507S
• 08800053022422: s-Clean SQ-SL Fixture / DSSFR5514
• 08800053022415: s-Clean SQ-SL Fixture / DSSFR5512
• 08800053022408: s-Clean SQ-SL Fixture / DSSFR5510
• 08800053022392: s-Clean SQ-SL Fixture / DSSFR5508