Cover Screw

GUDID 08800070204887

Izenimplant Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800070204887
• NIH Device Record Key: 9be5db21-9d7b-4ff1-a411-3619b1c7db2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover Screw
• Version Model Number: CSSN30S
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08800070204887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211090
• Premarket Notification: K230630

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-06

On-Brand Devices [Cover Screw]

• 08800070205020: CSTR40L
• 08800070205013: CSTR40M
• 08800070205006: CSTR40S
• 08800070204993: CSTM35L
• 08800070204986: CSTM35M
• 08800070204979: CSTM35S
• 08800070204962: CSSR40L
• 08800070204955: CSSR40M
• 08800070204948: CSSR40S
• 08800070204931: CSSM30L
• 08800070204924: CSSM30M
• 08800070204917: CSSM30S
• 08800070204900: CSSN30L
• 08800070204894: CSSN30M
• 08800070204887: CSSN30S
• 08800070204870: CSSX26