Perfit FS

GUDID 08800099966186

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800099966186
NIH Device Record Key3c97ecb4-a0d7-494b-bfb3-1f7aa0b406b6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfit FS
Version Model NumberFH I12 B3
Company DUNS688284886
Company NameVatech mcis Co., Ltd
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800099910714 [Primary]
GS108800099966186 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-08

On-Brand Devices [Perfit FS]

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

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