Perfit FS

GUDID 08800099965974

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800099965974
• NIH Device Record Key: 8b0b1900-5f7b-48d5-bd01-facdeb04bf4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfit FS
• Version Model Number: FH I10 C4
• 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	08800099919465 [Primary]
GS1	08800099965974 [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: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [Perfit FS]

• 08800099967831: FH B40 BL4
• 08800099967824: FH B40 BL3
• 08800099967817: FH B40 BL2
• 08800099967800: FH B40 BL1
• 08800099967794: FH B40 D4M
• 08800099967787: FH B40 D3M
• 08800099967770: FH B40 D2M
• 08800099967763: FH B40 C4M
• 08800099967756: FH B40 C3M
• 08800099967749: FH B40 C2M
• 08800099967732: FH B40 C1M
• 08800099967725: FH B40 B4M
• 08800099967718: FH B40 B3M
• 08800099967701: FH B40 B2M
• 08800099967695: FH B40 B1M
• 08800099967688: FH B40 A4M
• 08800099967671: FH B40 A3.5M
• 08800099967664: FH B40 A3M
• 08800099967657: FH B40 A2M
• 08800099967640: FH B40 A1M
• 08800099967633: FH B40 D4
• 08800099967626: FH B40 D3
• 08800099967619: FH B40 D2
• 08800099967602: FH B40 C4
• 08800099967596: FH B40 C3
• 08800099967589: FH B40 C2
• 08800099967572: FH B40 C1
• 08800099967565: FH B40 B4
• 08800099967558: FH B40 B3
• 08800099967541: FH B40 B2
• 08800099967534: FH B40 B1
• 08800099967527: FH B40 A4
• 08800099967510: FH B40 A3.5
• 08800099967503: FH B40 A3
• 08800099967497: FH B40 A2
• 08800099967480: FH B40 A1
• 08800099967473: FH B40 white
• 08800099967466: FH B32 BL4
• 08800099967459: FH B32 BL3
• 08800099967442: FH B32 BL2
• 08800099967435: FH B32 BL1
• 08800099967091: FH C16 BL4
• 08800099967084: FH C16 BL3
• 08800099967077: FH C16 BL2
• 08800099967060: FH C16 BL1
• 08800099966728: FH C14 BL4
• 08800099966711: FH C14 BL3
• 08800099966704: FH C14 BL2
• 08800099966698: FH C14 BL1
• 08800099966353: FH I12 BL4