Elastomeric Impression Material 50ml/bio-cartridge, 2 bio-cartridges/box

GUDID 06970402675127

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Silicone dental impression material
Primary Device ID06970402675127
NIH Device Record Key5f1b0a64-ef46-4b87-98e8-4a5d31d1fe30
Commercial Distribution StatusIn Commercial Distribution
Brand NameElastomeric Impression Material
Version Model NumberType 1 (Heavy Body Dispenser-mix Fast Set)
Catalog Number50ml/bio-cartridge, 2 bio-cartridges/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 Usefalse
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
GS106970402675127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-16
Device Publish Date2018-10-16

On-Brand Devices [Elastomeric Impression Material]

06970402675202Type 0 (Putty Hand-Mix)
06970402675196Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402675189Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402675172Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402675165Type 3 (Light Body)
06970402675158Type 2 (Regular Body)
06970402675141Type 1 (Heavy Body Auto-mix Fast Set)
06970402675134Type 1 (Heavy Body Auto-mix Normal Set)
06970402675127Type 1 (Heavy Body Dispenser-mix Fast Set)
06970402675110Type 1 (Heavy Body Dispenser-mix Normal Set)
06970402675103Type 0 (Bite Registration Dispenser-mix Fast Set)
06970402675097Type 0 (Bite Registration Dispenser-mix Normal Set
06970402675080Type 0 (Putty Auto-Mix)
06970402675073Type 0 (Putty Hand-Mix)
06970402675066Type 0 (Putty Hand-Mix)
06970402675059Type 0 (Putty Hand-Mix)
06970402675042Type 0 (Putty Hand-Mix)
06970402674984Impression kit
06970402674977Impression kit
06970402674953Impression kit
06970402670344Teeth Impression Kit
06970402670337Teeth Impression Kit
06970402670320Teeth Impression Kit
06970402670313Impression kit
06970402670214Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402670177Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402670160Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
06970402670153Type 3 (Light Body)
06970402670146Type 2 (Regular Body)
06970402670139Type 1 (Heavy Body Auto-mix Fast Set)
06970402670122Type 1 (Heavy Body Auto-mix Normal Set)
06970402670115Type 1 (Heavy Body Dispenser-mix Fast Set)
06970402670108Type 1 (Heavy Body Dispenser-mix Normal Set)
06970402670092Type 0 (Bite Registration Dispenser-mix Fast Set)
06970402670085Type 0 (Bite Registration Dispenser-mix Normal Set
06970402670078Type 0 (Putty Auto-Mix)
06970402670061Type 0 (Putty Hand-Mix)
06970402670054Type 0 (Putty Hand-Mix)
06970402670047Type 0 (Putty Hand-Mix)
06970402670030Type 0 (Putty Hand-Mix)
06970402670023Type 0 (Putty Hand-Mix)
06970402670016Type 0 (Putty Hand-Mix)
06970402675233Type 0 (Putty Hand-Mix)
06970402675226Type 0 (Putty Hand-Mix)
06970402675912Type 0 (Putty Hand-Mix)
06970402675745Type 0 (Putty Hand-Mix)

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