BruxZir 70-1182-BZE0544

GUDID D745701182BZE05441

BruxZir Esthetic GL Single Unit - A3.5

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic
Primary Device IDD745701182BZE05441
NIH Device Record Key7d59f838-c15c-49b0-8e97-35dbe392b75e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBruxZir
Version Model Number70-1182-BZE0544
Catalog Number70-1182-BZE0544
Company DUNS022761689
Company NamePrismatik Dentalcraft, Inc
Device Count40
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 Datetrue
Expiration Datefalse
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
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
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
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
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
HIBCCD745701182BZE05440 [Unit of Use]
HIBCCD745701182BZE05441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPOWDER, PORCELAIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-22
Device Publish Date2018-09-25

On-Brand Devices [BruxZir]

D745701182BZE05581BruxZir Esthetic GL Single Unit - White
D745701182BZE05571BruxZir Esthetic GL Single Unit - Bleach
D745701182BZE05561BruxZir Esthetic GL Single Unit - D4
D745701182BZE05551BruxZir Esthetic GL Single Unit - D3
D745701182BZE05541BruxZir Esthetic GL Single Unit - D2
D745701182BZE05531BruxZir Esthetic GL Single Unit - C4
D745701182BZE05521BruxZir Esthetic GL Single Unit - C3
D745701182BZE05511BruxZir Esthetic GL Single Unit - C2
D745701182BZE05501BruxZir Esthetic GL Single Unit - C1
D745701182BZE05491BruxZir Esthetic GL Single Unit - B4
D745701182BZE05481BruxZir Esthetic GL Single Unit - B3
D745701182BZE05471BruxZir Esthetic GL Single Unit - B2
D745701182BZE05461BruxZir Esthetic GL Single Unit - B1
D745701182BZE05451BruxZir Esthetic GL Single Unit - A4
D745701182BZE05441BruxZir Esthetic GL Single Unit - A3.5
D745701182BZE05431BruxZir Esthetic GL Single Unit - A3
D745701182BZE05421BruxZir Esthetic GL Single Unit - A2
D745701182BZE05411BruxZir Esthetic GL Single Unit - A1
D745701182BZE01800BruxZir Esthetic White 25mm Z
D745701182BZE01790BruxZir Esthetic White 20mm Z
D745701182BZE01780BruxZir Esthetic White 16mm Z
D745701182BZE01770BruxZir Esthetic White 14mm Z
D745701182BZE01760BruxZir Esthetic White 12mm Z
D745701182BZE01750BruxZir Esthetic Bleach 25mm Z
D745701182BZE01740BruxZir Esthetic Bleach 20mm Z
D745701182BZE01730BruxZir Esthetic Bleach 16mm Z
D745701182BZE01720BruxZir Esthetic Bleach 14mm Z
D745701182BZE01710BruxZir Esthetic Bleach 12mm Z
D745701182BZE01700BruxZir Esthetic D4 25mm Z
D745701182BZE01690BruxZir Esthetic D4 20mm Z
D745701182BZE01680BruxZir Esthetic D4 16mm Z
D745701182BZE01670BruxZir Esthetic D4 14mm Z
D745701182BZE01660BruxZir Esthetic D4 12mm Z
D745701182BZE01650BruxZir Esthetic D3 25mm Z
D745701182BZE01640BruxZir Esthetic D3 20mm Z
D745701182BZE01630BruxZir Esthetic D3 16mm Z
D745701182BZE01620BruxZir Esthetic D3 14mm Z
D745701182BZE01610BruxZir Esthetic D3 12mm Z
D745701182BZE01600BruxZir Esthetic D2 25mm Z
D745701182BZE01590BruxZir Esthetic D2 20mm Z
D745701182BZE01580BruxZir Esthetic D2 16mm Z
D745701182BZE01570BruxZir Esthetic D2 14mm Z
D745701182BZE01560BruxZir Esthetic D2 12mm Z
D745701182BZE01550BruxZir Esthetic C4 25mm Z
D745701182BZE01540BruxZir Esthetic C4 20mm Z
D745701182BZE01530BruxZir Esthetic C4 16mm Z
D745701182BZE01520BruxZir Esthetic C4 14mm Z
D745701182BZE01510BruxZir Esthetic C4 12mm Z
D745701182BZE01500BruxZir Esthetic C3 25mm Z
D745701182BZE01490BruxZir Esthetic C3 20mm Z

Trademark Results [BruxZir]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BRUXZIR
BRUXZIR
85332886 4714556 Live/Registered
James R. Glidewell Dental Ceramics Inc.
2011-05-27
BRUXZIR
BRUXZIR
77761757 3739663 Live/Registered
James R. Glidewell, Dental Ceramic, Inc.
2009-06-17

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