ASTRON LC LCS81

GUDID D810LCS818

DENTURE MATERIAL - 8 UNIT KIT - PACKAGE 8 EACH 6.3 GRAMS POWDER / 4 GRAMS LIQUID

ASTRON DENTAL CORPORATION

Custom-made mouthguard Custom-made mouthguard
Primary Device IDD810LCS818
NIH Device Record Keycad4176f-ebd9-4b05-8a1a-95caf5228882
Commercial Distribution StatusIn Commercial Distribution
Brand NameASTRON LC
Version Model NumberLCS81
Catalog NumberLCS81
Company DUNS056624901
Company NameASTRON DENTAL CORPORATION
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone847-726-8787
EmailASTRONCORP@AOL.COM
Phone847-726-8787
EmailASTRONCORP@AOL.COM

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD810LCS818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-09-24
Device Publish Date2016-09-07

On-Brand Devices [ASTRON LC]

D810LCSE11DENTURE MATERIAL - ECONO KIT - PACKAGE 180 GRAMS POWDER/120 GRAMS LIQUID
D810LCS818DENTURE MATERIAL - 8 UNIT KIT - PACKAGE 8 EACH 6.3 GRAMS POWDER / 4 GRAMS LIQUID
D810LCHE11DENTURE MATERIAL - ECONO KIT - PACKAGE 180 GRAMS POWDER/120 GRAMS LIQUID
D810LCH818DENTURE MATERIAL -8 PACK KIT - PACKAGE 8 EACH 6 GRAMS POWDER / 4 GRAMS LIQUID

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