Synthetic Polymer Teeth 1*6*16

GUDID 06970402660031

Huge Dental Material Co., Ltd.

Resin artificial teeth
Primary Device ID06970402660031
NIH Device Record Key03e5f29a-9afa-40ac-9e7e-4a06c8ac3e7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthetic Polymer Teeth
Version Model NumberKAILI
Catalog Number1*6*16
Company DUNS420283541
Company NameHuge Dental Material 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 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
GS106970402660031 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [Synthetic Polymer Teeth]

06970402660475Living Mould Guide
06970402660468Acrylic Teeth Shade Guide-Two layers
06970402660451Acrylic Teeth Shade Guide-Two layers
06970402660444Acrylic Teeth Shade Guide-Two layers
06970402660437Acrylic Teeth Shade Guide-MAIST
06970402660420Acrylic Teeth Shade Guide-MAIST
06970402660413Acrylic Shell
06970402660406Acrylic Shell
06970402660390Acrylic Shell
06970402660383SENIORS
06970402660376KAIPLUS
06970402660369KAIPLUS
06970402660352KAIPLUS
06970402660345KAIPLUS
06970402660338BLUEBELL
06970402660321BLUEBELL
06970402660314BLUEBELL
06970402660307BLUEBELL
06970402660291IMPLA
06970402660284IMPLA
06970402660277IMPLA
06970402660260IMPLA
06970402660253IMPLA
06970402660246KAITONG
06970402660239KAITONG
06970402660222KAITONG
06970402660215KAITONG
06970402660208KAIJING
06970402660192KAIJING
06970402660185KAIJING
06970402660178KAIJING
06970402660161SONNING
06970402660154SONNING
06970402660147SONNING
06970402660130SONNING
06970402660123KAIFENG
06970402660116KAIFENG
06970402660109KAIFENG
06970402660093KAIFENG
06970402660086MAIST
06970402660079MAIST
06970402660062MAIST
06970402660055MAIST
06970402660048KAILI
06970402660031KAILI
06970402660024KAILI
06970402660017KAILI

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