BruxZir Shaded 16 PLUS 70-1185-BXP0189

GUDID D745701185BXP01890

BruxZir Shaded 16 PLUS Milling Blank C2 16mm Z

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic
Primary Device IDD745701185BXP01890
NIH Device Record Key50f8240d-a561-4638-bc71-0065ad8cf98e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBruxZir Shaded 16 PLUS
Version Model Number70-1185-BXP0189
Catalog Number70-1185-BXP0189
Company DUNS022761689
Company NamePrismatik Dentalcraft, Inc
Device Count1
DM Exemptfalse
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD745701185BXP01890 [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 Date2020-06-12

On-Brand Devices [BruxZir Shaded 16 PLUS]

D745701185BXP03040BruxZir Shaded 16 PLUS Milling Blank White 30mm Z
D745701185BXP03030BruxZir Shaded 16 PLUS Milling Blank White 25mm Z
D745701185BXP03020BruxZir Shaded 16 PLUS Milling Blank White 20mm Z
D745701185BXP03010BruxZir Shaded 16 PLUS Milling Blank White 16mm Z
D745701185BXP03000BruxZir Shaded 16 PLUS Milling Blank White 14mm Z
D745701185BXP02990BruxZir Shaded 16 PLUS Milling Blank White 12mm Z
D745701185BXP02980BruxZir Shaded 16 PLUS Milling Blank White 10mm Z
D745701185BXP02970BruxZir Shaded 16 PLUS Milling Blank White GD 30mm Z
D745701185BXP02960BruxZir Shaded 16 PLUS Milling Blank White GD 25mm Z
D745701185BXP02950BruxZir Shaded 16 PLUS Milling Blank White GD 20mm Z
D745701185BXP02940BruxZir Shaded 16 PLUS Milling Blank White GD 16mm Z
D745701185BXP02930BruxZir Shaded 16 PLUS Milling Blank White GD 14mm Z
D745701185BXP02920BruxZir Shaded 16 PLUS Milling Blank White GD 12mm Z
D745701185BXP02910BruxZir Shaded 16 PLUS Milling Blank White GD 10mm Z
D745701185BXP02900BruxZir Shaded 16 PLUS Milling Blank BL3 30mm Z
D745701185BXP02890BruxZir Shaded 16 PLUS Milling Blank BL3 25mm Z
D745701185BXP02880BruxZir Shaded 16 PLUS Milling Blank BL3 20mm Z
D745701185BXP02870BruxZir Shaded 16 PLUS Milling Blank BL3 16mm Z
D745701185BXP02860BruxZir Shaded 16 PLUS Milling Blank BL3 14mm Z
D745701185BXP02850BruxZir Shaded 16 PLUS Milling Blank BL3 12mm Z
D745701185BXP02840BruxZir Shaded 16 PLUS Milling Blank BL3 10mm Z
D745701185BXP02830BruxZir Shaded 16 PLUS Milling Blank BL3 GD 30mm Z
D745701185BXP02820BruxZir Shaded 16 PLUS Milling Blank BL3 GD 25mm Z
D745701185BXP02810BruxZir Shaded 16 PLUS Milling Blank BL3 GD 20mm Z
D745701185BXP02800BruxZir Shaded 16 PLUS Milling Blank BL3 GD 16mm Z
D745701185BXP02790BruxZir Shaded 16 PLUS Milling Blank BL3 GD 14mm Z
D745701185BXP02780BruxZir Shaded 16 PLUS Milling Blank BL3 GD 12mm Z
D745701185BXP02770BruxZir Shaded 16 PLUS Milling Blank BL3 GD 10mm Z
D745701185BXP02760BruxZir Shaded 16 PLUS Milling Blank BL1 30mm Z
D745701185BXP02750BruxZir Shaded 16 PLUS Milling Blank BL1 25mm Z
D745701185BXP02740BruxZir Shaded 16 PLUS Milling Blank BL1 20mm Z
D745701185BXP02730BruxZir Shaded 16 PLUS Milling Blank BL1 16mm Z
D745701185BXP02720BruxZir Shaded 16 PLUS Milling Blank BL1 14mm Z
D745701185BXP02710BruxZir Shaded 16 PLUS Milling Blank BL1 12mm Z
D745701185BXP02700BruxZir Shaded 16 PLUS Milling Blank BL1 10mm Z
D745701185BXP02690BruxZir Shaded 16 PLUS Milling Blank BL1 GD 30mm Z
D745701185BXP02680BruxZir Shaded 16 PLUS Milling Blank BL1 GD 25mm Z
D745701185BXP02670BruxZir Shaded 16 PLUS Milling Blank BL1 GD 20mm Z
D745701185BXP02660BruxZir Shaded 16 PLUS Milling Blank BL1 GD 16mm Z
D745701185BXP02650BruxZir Shaded 16 PLUS Milling Blank BL1 GD 14mm Z
D745701185BXP02640BruxZir Shaded 16 PLUS Milling Blank BL1 GD 12mm Z
D745701185BXP02630BruxZir Shaded 16 PLUS Milling Blank BL1 GD 10mm Z
D745701185BXP02620BruxZir Shaded 16 PLUS Milling Blank D4 30mm Z
D745701185BXP02610BruxZir Shaded 16 PLUS Milling Blank D4 25mm Z
D745701185BXP02600BruxZir Shaded 16 PLUS Milling Blank D4 20mm Z
D745701185BXP02590BruxZir Shaded 16 PLUS Milling Blank D4 16mm Z
D745701185BXP02580BruxZir Shaded 16 PLUS Milling Blank D4 14mm Z
D745701185BXP02570BruxZir Shaded 16 PLUS Milling Blank D4 12mm Z
D745701185BXP02560BruxZir Shaded 16 PLUS Milling Blank D4 10mm Z
D745701185BXP02550BruxZir Shaded 16 PLUS Milling Blank D4 GD 30mm Z

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