Synthetic Polymer Teeth 1*28*1 (Maintenance box)

GUDID 06970402676827

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Resin artificial teeth
Primary Device ID06970402676827
NIH Device Record Key8147f16f-3010-4c7c-9e04-239ff2f0d909
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthetic Polymer Teeth
Version Model NumberIMPLA
Catalog Number1*28*1 (Maintenance box)
Company DUNS528184691
Company NameSHANDONG HUGE DENTAL MATERIAL CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970402676827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, Plastic, Teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-22

On-Brand Devices [Synthetic Polymer Teeth]

06970402677046Living Mould Guide
06970402677039Acrylic Teeth Shade Guide-Two layers
06970402677022Acrylic Teeth Shade Guide-Two layers
06970402677015Acrylic Teeth Shade Guide-Two layers
06970402677008Acrylic Teeth Shade Guide-MAIST
06970402676995Acrylic Teeth Shade Guide-MAIST
06970402676988Acrylic Shell
06970402676971Acrylic Shell
06970402676964Acrylic Shell
06970402676957SENIORS
06970402676940KAIPLUS
06970402676933KAIPLUS
06970402676926KAIPLUS
06970402676919KAIPLUS
06970402676902BLUEBELL
06970402676896BLUEBELL
06970402676889BLUEBELL
06970402676872BLUEBELL
06970402676865IMPLA
06970402676858IMPLA
06970402676841IMPLA
06970402676834IMPLA
06970402676827IMPLA
06970402676810KAITONG
06970402676803KAITONG
06970402676797KAITONG
06970402676780KAITONG
06970402676773KAIJING
06970402676766KAIJING
06970402676759KAIJING
06970402676742KAIJING
06970402676735SONNING
06970402676728SONNING
06970402676711SONNING
06970402676704SONNING
06970402676698KAIFENG
06970402676681KAIFENG
06970402676674KAIFENG
06970402676667KAIFENG
06970402676650MAIST
06970402676643MAIST
06970402676636MAIST
06970402676629MAIST
06970402676612KAILI
06970402676605KAILI
06970402676599KAILI
06970402676582KAILI

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