CCM Cast Abutment

GUDID 08800070219775

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800070219775
• NIH Device Record Key: 9087f529-24a1-4980-ad5d-14f85288d3a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCM Cast Abutment
• Version Model Number: CCASXN4030
• 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	08800070219775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230630

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

[08800070219775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [CCM Cast Abutment]

• 08800070219997: CCASXN4030S
• 08800070219980: CCASXN4010S
• 08800070219959: CCASXH4030S
• 08800070219942: CCASXH4010S
• 08800070219775: CCASXN4030
• 08800070219768: CCASXN4010
• 08800070219737: CCASXH4030
• 08800070219720: CCASXH4010
• 08800070220092: CCATRN4530S
• 08800070220085: CCATRN4510S
• 08800070220078: CCATMN4030S
• 08800070220061: CCATMN4010S
• 08800070220054: CCATRH4530S
• 08800070220047: CCATRH4510S
• 08800070220030: CCATMH4030S
• 08800070220023: CCATMH4010S
• 08800070220016: CCASRN4530S
• 08800070220009: CCASRN4510S
• 08800070219973: CCASRH4530S
• 08800070219966: CCASRH4510S
• 08800070219874: CCATRN4530
• 08800070219867: CCATRN4510
• 08800070219850: CCATMN4030
• 08800070219843: CCATMN4010
• 08800070219836: CCATRH4530
• 08800070219829: CCATRH4510
• 08800070219812: CCATMH4030
• 08800070219805: CCATMH4010
• 08800070219799: CCASRN4530
• 08800070219782: CCASRN4510
• 08800070219751: CCASRH4530
• 08800070219744: CCASRH4510