Ceramir Crown & Bridge QuikMix

GUDID 17310230400328

Ceramir Crown & Bridge QuikMix Kit

Directa AB

Glass ionomer dental cement
Primary Device ID17310230400328
NIH Device Record Key6b19fe37-014b-4d0c-896c-e0a79274259a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramir Crown & Bridge QuikMix
Version Model Number40032
Company DUNS353954381
Company NameDirecta AB
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

Customer Support Contacts

Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com
Phone+1-800-537 8765
Emailinfousa@directadental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS117310230400328 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-05
Device Publish Date2024-03-28

On-Brand Devices [Ceramir Crown & Bridge QuikMix]

17310230400328Ceramir Crown & Bridge QuikMix Kit
17310230102789Ceramir Crown & Bridge QuikMix Liquid 10g
17310230102772Ceramir Crown & Bridge QuikMix Powder 15g

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