RAYZir FS

GUDID 08800099968197

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800099968197
• NIH Device Record Key: da2f3070-218a-4251-b520-edfaebd7e7e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYZir FS
• Version Model Number: FH I12 A3.5M
• 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	08800099968197 [Unit of Use]
GS1	08800099969040 [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