s-Clean ScanHealing Abutment Screw

GUDID 08800053070553

s-Clean ScanHealing Abutment Screw (DSSHSM03O)

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800053070553
• NIH Device Record Key: aa4cd62f-b4af-4db5-9774-d842f4339824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean ScanHealing Abutment Screw
• Version Model Number: DSSHSM03O
• 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	08800053070553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241063

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: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [s-Clean ScanHealing Abutment Screw]

• 08800053071604: s-Clean ScanHealing Abutment Screw (DSSHSM02O)
• 08800053071598: s-Clean ScanHealing Abutment Screw (DSSHS07O)
• 08800053071581: s-Clean ScanHealing Abutment Screw (DSSHS06O)
• 08800053071574: s-Clean ScanHealing Abutment Screw (DSSHS05O)
• 08800053071567: s-Clean ScanHealing Abutment Screw (DSSHS04O)
• 08800053071550: s-Clean ScanHealing Abutment Screw (DSSHS03O)
• 08800053071543: s-Clean ScanHealing Abutment Screw (DSSHS02O)
• 08800053071536: s-Clean ScanHealing Abutment Screw (DSSHSM07)
• 08800053071529: s-Clean ScanHealing Abutment Screw(DSSHSM06)
• 08800053071512: s-Clean ScanHealing Abutment Screw (DSSHSM05)
• 08800053071505: s-Clean ScanHealing Abutment Screw (DSSHSM04)
• 08800053071499: s-Clean ScanHealing Abutment Screw (DSSHSM03)
• 08800053071482: s-Clean ScanHealing Abutment Screw (DSSHSM02)
• 08800053071475: s-Clean ScanHealing Abutment Screw (DSSHS07)
• 08800053071468: s-Clean ScanHealing Abutment Screw (DSSHS06)
• 08800053071451: s-Clean ScanHealing Abutment Screw (DSSHS05)
• 08800053071444: s-Clean ScanHealing Abutment Screw (DSSHS04)
• 08800053071437: s-Clean ScanHealing Abutment Screw (DSSHS03)
• 08800053071420: s-Clean ScanHealing Abutment Screw (DSSHS02)
• 08800053070591: s-Clean ScanHealing Abutment Screw (DSSHSM07O)
• 08800053070584: s-Clean ScanHealing Abutment Screw (DSSHSM06O)
• 08800053070577: s-Clean ScanHealing Abutment Screw (DSSHSM05O)
• 08800053070560: s-Clean ScanHealing Abutment Screw (DSSHSM04O)
• 08800053070553: s-Clean ScanHealing Abutment Screw (DSSHSM03O)