s-Clean TiN Half Coating Sole Abutment S-Line

GUDID 08806169160119

s-Clean Sole Abutment S-Line / D6.5 X L2.8 X H4 X T6.8mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169160119
• NIH Device Record Key: bf7546fc-37d7-4ac9-a260-63ae79812233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean TiN Half Coating Sole Abutment S-Line
• Version Model Number: DSSAZ65304HCT
• Company DUNS: 688204158
• 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	08806169160119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192688

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

[08806169160119]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [s-Clean TiN Half Coating Sole Abutment S-Line]

• 08806169160126: s-Clean Sole Abutment S-Line / D6.5 X L3.8 X H4 X T7.8mm
• 08806169160119: s-Clean Sole Abutment S-Line / D6.5 X L2.8 X H4 X T6.8mm
• 08806169160102: s-Clean Sole Abutment S-Line / D6.5 X L1.8 X H4 X T5.8mm
• 08806169159946: s-Clean Sole Abutment S-Line / D5.5 X L3.8 X H4 X T7.8mm
• 08806169159939: s-Clean Sole Abutment S-Line / D5.5 X L2.8 X H4 X T6.8mm
• 08806169159922: s-Clean Sole Abutment S-Line / D5.5 X L1.8 X H X T5.8mm
• 08806169159762: s-Clean Sole Abutment S-Line / D4.5 X L3.8 X H4 X T7.8mm
• 08806169159755: s-Clean Sole Abutment S-Line / D4.5 X L2.8 X H4 X T6.8mm
• 08806169159748: s-Clean Sole Abutment S-Line / D4.5 X L1.8 X H4 X T5.8mm