Chairside Zirconia

GUDID 08800099965547

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800099965547
• NIH Device Record Key: e6996aed-9c17-4b10-8002-ad98f78b1bd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chairside Zirconia
• Version Model Number: FH C16 A3
• Company DUNS: 688284886
• Company Name: Vatech mcis Co., Ltd
• Device Count: 5
• 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	08800099964908 [Primary]
GS1	08800099965547 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203590

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: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [Chairside Zirconia]

• 08800099965837: FH C16 D4M
• 08800099965820: FH C16 D3M
• 08800099965813: FH C16 D2M
• 08800099965806: FH C16 C4M
• 08800099965790: FH C16 C3M
• 08800099965783: FH C16 C2M
• 08800099965776: FH C16 C1M
• 08800099965769: FH C16 B4M
• 08800099965752: FH C16 B3M
• 08800099965745: FH C16 B2M
• 08800099965738: FH C16 B1M
• 08800099965721: FH C16 A4M
• 08800099965714: FH C16 A3.5M
• 08800099965707: FH C16 A3M
• 08800099965691: FH C16 A2M
• 08800099965684: FH C16 A1M
• 08800099965677: FH C16 D4
• 08800099965660: FH C16 D3
• 08800099965653: FH C16 D2
• 08800099965646: FH C16 C4
• 08800099965639: FH C16 C3
• 08800099965622: FH C16 C2
• 08800099965615: FH C16 C1
• 08800099965608: FH C16 B4
• 08800099965592: FH C16 B3
• 08800099965585: FH C16 B2
• 08800099965578: FH C16 B1
• 08800099965561: FH C16 A4
• 08800099965554: FH C16 A3.5
• 08800099965547: FH C16 A3
• 08800099965530: FH C16 A2
• 08800099965523: FH C16 A1
• 08800099965516: FH C14 D4M
• 08800099965509: FH C14 D3M
• 08800099965493: FH C14 D2M
• 08800099965486: FH C14 C4M
• 08800099965479: FH C14 C3M
• 08800099965462: FH C14 C2M
• 08800099965455: FH C14 C1M
• 08800099965448: FH C14 B4M
• 08800099965431: FH C14 B3M
• 08800099965424: FH C14 B2M
• 08800099965417: FH C14 B1M
• 08800099965400: FH C14 A4M
• 08800099965394: FH C14 A3.5M
• 08800099965387: FH C14 A3M
• 08800099965370: FH C14 A2M
• 08800099965363: FH C14 A1M
• 08800099965356: FH C14 D4
• 08800099965349: FH C14 D3