i-Clean Plastic Cylinder

GUDID 08800053040006

i-Clean Plastic Cylinder (DIOPWOS)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800053040006
• NIH Device Record Key: f37b615c-fd42-45eb-9adf-f41138b6e137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Plastic Cylinder
• Version Model Number: DIOPWOS
• 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	08800053040006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230307

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

[08800053040006]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [i-Clean Plastic Cylinder]

• 08800053023047: Dental Implant Instrument / i-Clean Plastic Cylinder
• 08800053023030: Dental Implant Instrument / i-Clean Plastic Cylinder
• 08800053040006: i-Clean Plastic Cylinder (DIOPWOS)
• 08800053039994: i-Clean Plastic Cylinder (DIOPWNS)
• 08800053037907: i-Clean Plastic Cylinder (DIOPNS)
• 08800053037891: i-Clean Plastic Cylinder (DIOPOS)