Glidewell Zirconia Primer 70-1198-PVC00040

GUDID D745701198PVC00040

Glidewell Zirconia Primer 2X0.1ml

James R. Glidewell, Dental Ceramics, Inc.

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Primary Device IDD745701198PVC00040
NIH Device Record Keye61bae3a-468f-4dd9-9686-14b811048bef
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlidewell Zirconia Primer
Version Model Number70-1198-PVC0004
Catalog Number70-1198-PVC00040
Company DUNS021228671
Company NameJames R. Glidewell, Dental Ceramics, Inc.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD745701198PVC00040 [Unit of Use]
HIBCCD745701198PVC00041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-27
Device Publish Date2022-07-19

On-Brand Devices [Glidewell Zirconia Primer]

D745701198PVC00040Glidewell Zirconia Primer 2X0.1ml
D745701198PVC00020Glidewell Zirconia Primer 1X0.1ml

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