A-Silicone for Bite Registration 50ml/bio-cartridge, 2 bio-cartridges/box

GUDID 06970402675837

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Silicone dental impression material
Primary Device ID06970402675837
NIH Device Record Key8a4e7452-e846-481e-a00d-8b18a6f76f8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameA-Silicone for Bite Registration
Version Model NumberDispenser-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
GS106970402675837 [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 Date2020-12-16
Device Publish Date2020-12-08

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