FormCore DC

GUDID 10852253006219

Dental Composite Resin for Core Build-up

J. MORITA U.S.A., INC

Dental composite resin
Primary Device ID10852253006219
NIH Device Record Keye81f0155-4a59-401f-8cd2-6a1064b055d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFormCore DC
Version Model Number28700100
Company DUNS021866033
Company NameJ. MORITA U.S.A., INC
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 Usetrue
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
GS110852253006219 [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 Number4
Public Version Date2020-01-28
Device Publish Date2016-09-22

On-Brand Devices [FormCore DC ]

18522530060211Dental Composite Resin for Core Build-up
10852253006219Dental Composite Resin for Core Build-up

Trademark Results [FormCore DC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORMCORE DC
FORMCORE DC
78958335 3286386 Dead/Cancelled
J. Morita USA, Inc.
2006-08-23

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