RAYZir FS

GUDID 08800099968845

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: 08800099968845
• NIH Device Record Key: c3e0f5b5-37f8-4869-983d-c69b72fa8a3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYZir FS
• Version Model Number: FH C16 D4M
• 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	08800099968845 [Unit of Use]
GS1	08800099969699 [Primary]

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: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [RAYZir FS]

• 08800099968845: FH C16 D4M
• 08800099968838: FH C16 D3M
• 08800099968821: FH C16 D2M
• 08800099968814: FH C16 C4M
• 08800099968807: FH C16 C3M
• 08800099968791: FH C16 C2M
• 08800099968784: FH C16 C1M
• 08800099968777: FH C16 B4M
• 08800099968760: FH C16 B3M
• 08800099968753: FH C16 B2M
• 08800099968746: FH C16 B1M
• 08800099968739: FH C16 A4M
• 08800099968722: FH C16 A3.5M
• 08800099968715: FH C16 A3M
• 08800099968708: FH C16 A2M
• 08800099968692: FH C16 A1M
• 08800099968685: FH C16 D4
• 08800099968678: FH C16 D3
• 08800099968661: FH C16 D2
• 08800099968654: FH C16 C4
• 08800099968647: FH C16 C3
• 08800099968630: FH C16 C2
• 08800099968623: FH C16 C1
• 08800099968616: FH C16 B4
• 08800099968609: FH C16 B3
• 08800099968593: FH C16 B2
• 08800099968586: FH C16 B1
• 08800099968579: FH C16 A4
• 08800099968562: FH C16 A3.5
• 08800099968555: FH C16 A3
• 08800099968548: FH C16 A2
• 08800099968531: FH C16 A1
• 08800099968524: FH C14 D4M
• 08800099968517: FH C14 D3M
• 08800099968500: FH C14 D2M
• 08800099968494: FH C14 C4M
• 08800099968487: FH C14 C3M
• 08800099968470: FH C14 C2M
• 08800099968463: FH C14 C1M
• 08800099968456: FH C14 B4M
• 08800099968449: FH C14 B3M
• 08800099968432: FH C14 B2M
• 08800099968425: FH C14 B1M
• 08800099968418: FH C14 A4M
• 08800099968401: FH C14 A3.5M
• 08800099968395: FH C14 A3M
• 08800099968388: FH C14 A2M
• 08800099968371: FH C14 A1M
• 08800099968364: FH C14 D4
• 08800099968357: FH C14 D3