s-Clean Pre-Milled Abutment (A-Type)

GUDID 08800053008853

Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10N)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: 08800053008853
• NIH Device Record Key: 6ae10fe4-fe54-4518-9d5f-b3c6295a416f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Pre-Milled Abutment (A-Type)
• Version Model Number: DSCBA10N
• 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: 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	08800053008853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210362

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

[08800053008853]

Moist Heat or Steam Sterilization

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 Pre-Milled Abutment (A-Type)]

• 08800053008945: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14NS)
• 08800053008938: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10NS)
• 08800053008921: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14HS)
• 08800053008914: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10HS)
• 08800053008860: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14N)
• 08800053008853: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10N)
• 08800053008846: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14H)
• 08800053008839: Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10H)