MiYO Esthetic System MI997

GUDID 00817340025941

JENSEN INDUSTRIES INC.

Dental porcelain/ceramic restoration kit
Primary Device ID00817340025941
NIH Device Record Keyea6ac0da-41ef-4667-b1d0-0f54d297f5e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiYO Esthetic System
Version Model NumberMiYO Esthetic System Chairside Kit
Catalog NumberMI997
Company DUNS060018587
Company NameJENSEN INDUSTRIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817340025941 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

On-Brand Devices [MiYO Esthetic System]

00817340025118MiYO Enamel Effect Liquid Jensen XT
00817340025125MiYO Enamel Effect Liquid Jensen XT 15ml
00817340025538MiYO Gingival Thistle Paste 4g
00817340025521MiYO Gingival Sable Paste 4g
00817340025514MiYO Trans Lumin Plus Fluor paste 4g
00817340025507MiYO Trans Slate Fluor paste 4g
00817340025491MiYO Trans Cobalt Fluor paste 4g
00817340025484MiYO Trans Sage Fluor paste 4g
00817340025446MiYO Gingival Salmon Paste 4g
00817340025439MiYO Gingival Trans Copper Paste 4g
00817340025422MiYO Gingival Trans Raspberry Paste 4g
00817340025415MiYO Gingival Sorbet Paste 4g
00817340025408MiYO Gingival Merlot Paste 4g
00817340025392MiYO Gingival Plum Paste 4g
00817340025385MiYO Gingival Trans Midnight Paste 4g
00817340025378MiYO Gingival Crimson Paste 4g
00817340025361MiYO Gingival Flamingo Paste 4g
00817340025354MiYO Trans Shade D Fluor paste 4g
00817340025347MiYO Trans Shade C Fluor paste 4g
00817340025330MiYO Trans Shade B Fluor paste 4g
00817340025323MiYO Trans Shade A Fluor paste 4g
00817340025316MiYO Trans Lumin Fluor paste 4g
00817340025309MiYO Trans Smoke Fluor paste 4g
00817340025248MiYO Mamelon Pumpkin Fluor paste 4g
00817340025231MiYO Mamelon Coral Fluor paste 4g
00817340025224MiYO Mamelon Wheat Fluor paste 4g
00817340025217MiYO Halo Autumn Fluor paste 4g
00817340025200MiYO Halo Spring Fluor paste 4g
00817340025194MiYO Trans Clementine Fluor paste 4g
00817340025187MiYO Trans Straw Fluor paste 4g
00817340025170MiYO Trans Lotus Fluor paste 4g
00817340025163MiYO Trans Storm Fluor paste 4g
00817340025149MiYO Linen Fluor paste 4g
00817340025132MiYO Snow Fluor paste 4g
00817340025477MiYO Gingival Structure Frost paste 4g
00817340025460MiYO Gingival Structure Rouge paste 4g
00817340025453MiYO Gingival Structure Orchid paste 4g
00817340025286MiYO Structure Enamel Flour paste 4g
00817340025255MiYO Structure Window Flour paste 4g
00817340025156MiYO Fissure Flour powder 4g
00817340025644MiYO Esthetic System Chairside Kit
00817340025743MiYO Gingival Venule Powder 4g
00817340025705MiYO Structure Enamel High Fusing Paste 4g
00817340025699MiYO Structure Window High Fusing Paste 4g
00817340025675MiYO Gingival Carnation Paste 4g
00817340025668MiYO Trans Sunflower Fluor Paste 4g
00817340025651MiYO Gingival Glaze paste no Fluor 4g
00817340025750MiYO Gingival Esthetic System Kit
00817340025682MiYO Trans Garnet Paste 4g
00817340025774MiYO Gingival Hibiscus Paste 4g
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