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

GUDID 08800053033701

Dental Implant System / s-Clean Pre-Milled Abutment Mini (A-Type) (DSCBAM10HS)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: 08800053033701
• NIH Device Record Key: 4594a2b8-00d4-422e-a5a9-f3af174bb24d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Pre-Milled Abutment Mini (A-Type)
• Version Model Number: DSCBAM10HS
• 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	08800053033701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210410

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

Moist Heat or Steam Sterilization

[08800053033701]

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 Mini (A-Type)]

• 08800053033718: Dental Implant System / s-Clean Pre-Milled Abutment Mini (A-Type) (DSCBAM10NS)
• 08800053033701: Dental Implant System / s-Clean Pre-Milled Abutment Mini (A-Type) (DSCBAM10HS)
• 08800053033671: Dental Implant System / s-Clean Pre-Milled Abutment Mini (A-Type) (DSCBAM10N)
• 08800053033664: Dental Implant System / s-Clean Pre-Milled Abutment Mini (A-Type) (DSCBAM10H)