s-Clean Couple Abutment

GUDID 08806169107862

s-Clean Couple Abutment (DSCA4535N4S)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169107862
• NIH Device Record Key: c8a999d8-f9f5-45cf-9f34-b4f47c7a984f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Couple Abutment
• Version Model Number: DSCA4535N4S
• 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	08806169107862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230126

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

[08806169107862]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

On-Brand Devices [s-Clean Couple Abutment]

• 08806169170606: s-Clean Couple Abutment (DSCA5555H4)
• 08806169170590: s-Clean Couple Abutment (DSCA5545H4)
• 08806169170583: s-Clean Couple Abutment (DSCA5535H4)
• 08806169170576: s-Clean Couple Abutment (DSCA5525H4)
• 08806169170569: s-Clean Couple Abutment (DSCA5520H4)
• 08806169170552: s-Clean Couple Abutment (DSCA5515H4)
• 08806169170545: s-Clean Couple Abutment (DSCA5510H4)
• 08806169170538: s-Clean Couple Abutment (DSCA4555H4)
• 08806169170521: s-Clean Couple Abutment (DSCA4545H4)
• 08806169170514: s-Clean Couple Abutment (DSCA4535H4)
• 08806169170507: s-Clean Couple Abutment (DSCA4525H4)
• 08806169170491: s-Clean Couple Abutment (DSCA4520H4)
• 08806169170484: s-Clean Couple Abutment (DSCA4515H4)
• 08806169170477: s-Clean Couple Abutment (DSCA4510H4)
• 08806169108616: s-Clean Couple Abutment (DSCA6555H4S)
• 08806169108609: s-Clean Couple Abutment (DSCA6545H4S)
• 08806169108593: s-Clean Couple Abutment (DSCA6535H4S)
• 08806169108586: s-Clean Couple Abutment (DSCA6525H4S)
• 08806169108579: s-Clean Couple Abutment (DSCA6520H4S)
• 08806169108562: s-Clean Couple Abutment (DSCA6515H4S)
• 08806169108555: s-Clean Couple Abutment (DSCA6510H4S)
• 08806169108548: s-Clean Couple Abutment (DSCA5555H4S)
• 08806169108531: s-Clean Couple Abutment (DSCA5545H4S)
• 08806169108524: s-Clean Couple Abutment (DSCA5535H4S)
• 08806169108517: s-Clean Couple Abutment (DSCA5525H4S)
• 08806169108302: s-Clean Couple Abutment (DSCA5520H4S)
• 08806169108296: s-Clean Couple Abutment (DSCA5515H4S)
• 08806169108289: s-Clean Couple Abutment (DSCA5510H4S)
• 08806169108272: s-Clean Couple Abutment (DSCA4555H4S)
• 08806169108265: s-Clean Couple Abutment (DSCA4545H4S)
• 08806169108258: s-Clean Couple Abutment (DSCA4535H4S)
• 08806169108241: s-Clean Couple Abutment (DSCA4525H4S)
• 08806169108234: s-Clean Couple Abutment (DSCA4520H4S)
• 08806169108227: s-Clean Couple Abutment (DSCA4515H4S)
• 08806169108210: s-Clean Couple Abutment (DSCA4510H4S)
• 08806169108203: s-Clean Couple Abutment (DSCA6555N4S)
• 08806169108197: s-Clean Couple Abutment (DSCA6545N4S)
• 08806169108180: s-Clean Couple Abutment (DSCA6535N4S)
• 08806169108173: s-Clean Couple Abutment (DSCA6525N4S)
• 08806169108166: s-Clean Couple Abutment (DSCA6520N4S)
• 08806169108159: s-Clean Couple Abutment (DSCA6515N4S)
• 08806169108142: s-Clean Couple Abutment (DSCA6510N4S)
• 08806169108135: s-Clean Couple Abutment (DSCA5555N4S)
• 08806169107947: s-Clean Couple Abutment (DSCA5545N4S)
• 08806169107930: s-Clean Couple Abutment (DSCA5535N4S)
• 08806169107923: s-Clean Couple Abutment (DSCA5525N4S)
• 08806169107916: s-Clean Couple Abutment (DSCA5520N4S)
• 08806169107909: s-Clean Couple Abutment (DSCA5515N4S)
• 08806169107893: s-Clean Couple Abutment (DSCA5510N4S)
• 08806169107886: s-Clean Couple Abutment (DSCA4555N4S)