Rebilda DC 1404

GUDID E22114041

Dual-curing flowable core build-up and post luting system

VOCO GmbH

Dental composite resin
Primary Device IDE22114041
NIH Device Record Key234bd557-7a1a-4001-9707-cdc0fc9a1a64
Commercial Distribution StatusIn Commercial Distribution
Brand NameRebilda DC
Version Model Number1404
Catalog Number1404
Company DUNS316699578
Company NameVOCO GmbH
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

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22114041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, 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 Date2016-08-31

On-Brand Devices [Rebilda DC]

E22114051Dual-curing flowable core build-up and post luting system
E22114041Dual-curing flowable core build-up and post luting system
E22114031Dual-curing flowable core build-up and post luting system
E22114021Rebilda DC is a dual-curing, radiopaque, flowable composite indicated for core build-ups
E22113981Dual-curing flowable core build-up and post luting system
E22113971Dual-curing flowable core build-up and post luting system
E22113961Dual-curing flowable core build-up and post luting system
E22113951Rebilda DC is a dual-curing, radiopaque, flowable composite indicated for core build-ups
E22114061Dual-curing flowable core build-up and post luting system
E22113991Dual-curing flowable core build-up and post luting system

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