ASTRON 1180 1180EC1

GUDID D8101180EC11

DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS

ASTRON DENTAL CORPORATION

Custom-made mouthguard
Primary Device IDD8101180EC11
NIH Device Record Key8ec45dbe-e50a-4eeb-973d-636059bcfbbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameASTRON 1180
Version Model Number1180EC1
Catalog Number1180EC1
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
HIBCCD8101180EC11 [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 1180]

D8101180MFT11DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS
D8101180LFT11DENTURE MATERIAL - 10 UNIT KIT - 10 each 25 gram units
D8101180EC11DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS

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