MontBlanc

GUDID 08800055728247

ARUM DENTISTRY Co., Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800055728247
• NIH Device Record Key: 82ea93b1-4cfd-41ed-95d4-c9c47e857fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MontBlanc
• Version Model Number: MontBlanc-ZR-18
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY 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	08800055728247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223253

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [MontBlanc]

• 08800055741727: MontBlanc-WR-10-A35
• 08800055741628: MontBlanc-WR-10-A3
• 08800055741529: MontBlanc-WR-10-A2
• 08800055741499: MontBlanc-WR-25-A1
• 08800055741482: MontBlanc-WR-22-A1
• 08800055741475: MontBlanc-WR-20-A1
• 08800055741468: MontBlanc-WR-18-A1
• 08800055741451: MontBlanc-WR-16-A1
• 08800055741444: MontBlanc-WR-14-A1
• 08800055741437: MontBlanc-WR-12-A1
• 08800055741420: MontBlanc-WR-10-A1
• 08800055741413: MontBlanc-WR-30
• 08800055741406: MontBlanc-WR-28
• 08800055741390: MontBlanc-WR-25
• 08800055741383: MontBlanc-WR-22
• 08800055741376: MontBlanc-WR-20
• 08800055741369: MontBlanc-WR-18
• 08800055741352: MontBlanc-WR-16
• 08800055741345: MontBlanc-WR-14
• 08800055741338: MontBlanc-WR-12
• 08800055741321: MontBlanc-WR-10
• 08800055728100: MontBlanc-WR-10-D4
• 08800055728001: MontBlanc-WR-10-D3
• 08800055727905: MontBlanc-WR-10-D2
• 08800055727806: MontBlanc-WR-10-C4
• 08800055727707: MontBlanc-WR-10-C3
• 08800055727608: MontBlanc-WR-10-C2
• 08800055727509: MontBlanc-WR-10-C1
• 08800055727400: MontBlanc-WR-10-B4
• 08800055727301: MontBlanc-WR-10-B3
• 08800055727202: MontBlanc-WR-10-B2
• 08800055727103: MontBlanc-WR-10-B1
• 08800055727004: MontBlanc-WR-10-A4
• 08800055741796: MontBlanc-WR-25-A35
• 08800055741789: MontBlanc-WR-22-A35
• 08800055741772: MontBlanc-WR-20-A35
• 08800055741765: MontBlanc-WR-18-A35
• 08800055741758: MontBlanc-WR-16-A35
• 08800055741741: MontBlanc-WR-14-A35
• 08800055741734: MontBlanc-WR-12-A35
• 08800055741710: MontBlanc-WR-30-A3
• 08800055741703: MontBlanc-WR-28-A3
• 08800055741697: MontBlanc-WR-25-A3
• 08800055741680: MontBlanc-WR-22-A3
• 08800055741673: MontBlanc-WR-20-A3
• 08800055741666: MontBlanc-WR-18-A3
• 08800055741659: MontBlanc-WR-16-A3
• 08800055741642: MontBlanc-WR-14-A3
• 08800055741635: MontBlanc-WR-12-A3
• 08800055741611: MontBlanc-WR-30-A2