Perfit ZR

GUDID 08800099907516

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800099907516
NIH Device Record Key11bffa22-0ea7-4db8-b771-d55c09c1fa71
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfit ZR
Version Model NumberNU 14 C2TM W
Company DUNS688284886
Company NameVatech mcis Co., Ltd
Device Count1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800099907516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-23
Device Publish Date2021-11-18

On-Brand Devices [Perfit ZR]

08800099907912NU 25 D4TM W
08800099907905NU 22 D4TM W
08800099907899NU 20 D4TM W
08800099907882NU 18 D4TM W
08800099907875NU 16 D4TM W
08800099907868NU 14 D4TM W
08800099907851NU 12 D4TM W
08800099907844NU 25 D3TM W
08800099907837NU 22 D3TM W
08800099907820NU 20 D3TM W
08800099907813NU 18 D3TM W
08800099907806NU 16 D3TM W
08800099907790NU 14 D3TM W
08800099907783NU 12 D3TM W
08800099907639NU 25 C3TM W
08800099907622NU 22 C3TM W
08800099907615NU 20 C3TM W
08800099907608NU 18 C3TM W
08800099907592NU 16 C3TM W
08800099907585NU 14 C3TM W
08800099907578NU 12 C3TM W
08800099907561NU 25 C2TM W
08800099907554NU 22 C2TM W
08800099907547NU 20 C2TM W
08800099907530NU 18 C2TM W
08800099907523NU 16 C2TM W
08800099907516NU 14 C2TM W
08800099907509NU 12 C2TM W
08800099907493NU 25 C1TM W
08800099907486NU 22 C1TM W
08800099907479NU 20 C1TM W
08800099907462NU 18 C1TM W
08800099907455NU 16 C1TM W
08800099907448NU 14 C1TM W
08800099907431NU 12 C1TM W
08800099907424NU 25 B4TM W
08800099907417NU 22 B4TM W
08800099907400NU 20 B4TM W
08800099907394NU 18 B4TM W
08800099907387NU 16 B4TM W
08800099907370NU 14 B4TM W
08800099907363NU 12 B4TM W
08800099907356NU 25 B3TM W
08800099907349NU 22 B3TM W
08800099907332NU 20 B3TM W
08800099907325NU 18 B3TM W
08800099907318NU 16 B3TM W
08800099907301NU 14 B3TM W
08800099907295NU 12 B3TM W
08800099907288NU 25 B2TM W

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