s-Clean MU Couple Abutment

GUDID 08806169191748

Dental Implant Abutment / s-Clean MU Couple Abutment / DSMCA4820HS

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169191748
• NIH Device Record Key: e99bd463-8988-49d3-8a96-1aeed70929d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean MU Couple Abutment
• Version Model Number: DSMCA4820HS
• 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	08806169191748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150344

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

[08806169191748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [s-Clean MU Couple Abutment]

• 08806169191762: Dental Implant Abutment / s-Clean MU Couple Abutment / DSMCA4840HS
• 08806169191755: Dental Implant Abutment / s-Clean MU Couple Abutment / DSMCA4830HS
• 08806169191748: Dental Implant Abutment / s-Clean MU Couple Abutment / DSMCA4820HS
• 08806169191731: Dental Implant Abutment / s-Clean MU Couple Abutment / DSMCA4810HS