EXACTA Cement Xtra 7450

GUDID 00815619021175

EXACTA Cement Xtra 11g Syringe

EXACTA DENTAL PRODUCTS INC

Dental composite resin
Primary Device ID00815619021175
NIH Device Record Key39fb0867-768c-44e1-8b9b-22fc27069396
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXACTA Cement Xtra
Version Model Number7450
Catalog Number7450
Company DUNS016325552
Company NameEXACTA DENTAL PRODUCTS INC
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
GS100815619021175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

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 Date2016-09-16

On-Brand Devices [EXACTA Cement Xtra]

00815619021175EXACTA Cement Xtra 11g Syringe
00815619021168EXACTA Cement Xtra 120g Cartridge
00815619020468EXACTA Cement Xtra 11g Syringe
00815619020451EXACTA Cement Xtra 120g Syringe

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.