KDF Zirconia Disc

GUDID 04560230234027

DENKEN-HIGHDENTAL CO., LTD.

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• Primary Device ID: 04560230234027
• NIH Device Record Key: 3dcef399-ace1-4e9f-9bbb-f5607af540ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KDF Zirconia Disc
• Version Model Number: MU-A2/18mm
• Company DUNS: 693815540
• Company Name: DENKEN-HIGHDENTAL 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	04560230234027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221429

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [KDF Zirconia Disc]

• 04560230233808: MU-BL2/35mm
• 04560230233792: MU-BL2/30mm
• 04560230233785: MU-BL2/25mm
• 04560230233778: MU-BL2/22mm
• 04560230233761: MU-BL2/20mm
• 04560230233754: MU-BL2/18mm
• 04560230233747: MU-BL2/16mm
• 04560230233730: MU-BL2/14mm
• 04560230233723: MU-BL2/10mm
• 04560230233983: MU-A1/35mm
• 04560230233976: MU-A1/30mm
• 04560230233969: MU-A1/25mm
• 04560230233952: MU-A1/22mm
• 04560230233945: MU-A1/20mm
• 04560230233938: MU-A1/18mm
• 04560230233921: MU-A1/16mm
• 04560230233914: MU-A1/14mm
• 04560230233907: MU-A1/10mm
• 04560230234072: MU-A2/35mm
• 04560230234065: MU-A2/30mm
• 04560230234058: MU-A2/25mm
• 04560230234041: MU-A2/22mm
• 04560230234034: MU-A2/20mm
• 04560230234027: MU-A2/18mm
• 04560230234010: MU-A2/16mm
• 04560230234003: MU-A2/14mm
• 04560230233990: MU-A2/10mm