s-Clean TiN Partial Coating Sub-octa Abutment

GUDID 08806169173089

Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA481PCT

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169173089
• NIH Device Record Key: 6ea8db75-6829-4e82-b497-d5f82fbe2015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean TiN Partial Coating Sub-octa Abutment
• Version Model Number: DSOA481PCT
• 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	08806169173089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171694

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

[08806169173089]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-17
• Device Publish Date: 2022-11-09

On-Brand Devices [s-Clean TiN Partial Coating Sub-octa Abutment]

• 08806169173126: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA485PCT
• 08806169173119: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA484PCT
• 08806169173102: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA483PCT
• 08806169173096: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA482PCT
• 08806169173089: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA481PCT
• 08806169173072: Dental Implant Abutment / s-Clean TiN Partial Coating Sub-octa Abutment / DSOA480PCT