Signum universal bond 66079923

GUDID J014660799230

Signum universal bond (set)

Kulzer GmbH

Dental prosthesis veneer resin
Primary Device IDJ014660799230
NIH Device Record Keyeea52743-ca5c-45fa-84ce-06d247ae93c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignum universal bond
Version Model Number66079923
Catalog Number66079923
Company DUNS315666321
Company NameKulzer GmbH
Device Count1
DM Exempttrue
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 Datetrue
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)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx
Phone+1(800)431-1785
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ014660799230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBDCoating, filling material, resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-29
Device Publish Date2024-11-21

On-Brand Devices [Signum universal bond]

J014660799270Signum universal bond II, 4 ml
J014660799260Signum universal bond I, 4 ml
J014660799230Signum universal bond (set)

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