Bosworth SuperEBA 0921007

GUDID H66809210071

15 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set

Harry J Bosworth Company

Ethoxy benzoic acid dental cement
Primary Device IDH66809210071
NIH Device Record Key5e2831a5-15bf-4987-bab0-fc9495d4d464
Commercial Distribution StatusIn Commercial Distribution
Brand NameBosworth SuperEBA
Version Model Number0921007
Catalog Number0921007
Company DUNS014769301
Company NameHarry J Bosworth Company
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)333-3131
Emailtschwear@keystoneind.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH66809210071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACEMENT, DENTAL

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 Date2016-09-15

On-Brand Devices [Bosworth SuperEBA]

H668092101411 oz ZOE Cement Liquid
H668092101312 oz ZOE Cement Pwd, Reg
H668092101212 oz ZOE Cement Pwd, Fast
H668092101016.5 ml ZOE Cement Liquid
H6680921009115 g ZOE Cement Pwd, Reg
H6680921008115 g ZOE Cement Pwd, Fast
H6680921007R115 g Pwd & 6.5 ml Liq Cement Kit, Reg Set
H6680921007F115 g Pwd & 6.5 ml Liq Cement Kit, Fast Set
H6680921007115 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set

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