ZRT

GUDID D831STZR120

PRIMOTEC LLC

Dental appliance fabrication material, ceramic
Primary Device IDD831STZR120
NIH Device Record Keyb5003557-a66e-4e37-a7cb-1ee49fc21b07
Commercial Distribution StatusIn Commercial Distribution
Brand NameZRT
Version Model NumberSTZR12
Company DUNS153454736
Company NamePRIMOTEC LLC
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 Usefalse
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
HIBCCD831STZR120 [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 Number4
Public Version Date2018-07-24
Device Publish Date2016-09-23

On-Brand Devices [ZRT]

D831STZR300STZR30
D831STZR250STZR25
D831STZR220STZR22
D831STZR200STZR20
D831STZR180STZR18
D831STZR160STZR16
D831STZR140STZR14
D831STZR120STZR12
D831STZR100STZR10

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