FDA.reportPublic FDA data

BruxZir Esthetic

Primary DI
D745701183BEP00081
Brand
BruxZir Esthetic
Company
Prismatik Dentalcraft, Inc
Model
70-1183-BEP0008
Catalog number
70-1183-BEP0008
Device description
BruxZir Esthetic GL Single Unit Block - B3
Published
2021-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213425000BruxZir EstheticPrismatik Dentalcraft, Inc.2021-11-17EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701183BEP00081PrimaryHIBCC0
D745701183BEP00080Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
022761689
Device count
40
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701182BZE05590BruxZir®70-1182-BZE055970-1182-BZE05592026-07-07
D745701182BZE05600BruxZir®70-1182-BZE056070-1182-BZE05602026-07-07
D745701182BZE05610BruxZir®70-1182-BZE056170-1182-BZE05612026-07-07
D745701182BZE05640BruxZir®70-1182-BZE056470-1182-BZE05642026-07-07
D745701182BZE05760BruxZir®70-1182-BZE057670-1182-BZE05762026-07-07
D745701182BZE05770BruxZir®70-1182-BZE057770-1182-BZE05772026-07-07
D745701182BZE05780BruxZir®70-1182-BZE057870-1182-BZE05782026-07-07
D745701182BZE05790BruxZir®70-1182-BZE057970-1182-BZE05792026-07-07
D745701182BZE05820BruxZir®70-1182-BZE058270-1182-BZE05822026-07-07
D745701182BZE05940BruxZir®70-1182-BZE059470-1182-BZE05942026-07-07
D745701182BZE05950BruxZir®70-1182-BZE059570-1182-BZE05952026-07-07
D745701182BZE05960BruxZir®70-1182-BZE059670-1182-BZE05962026-07-07
D745701182BZE05970BruxZir®70-1182-BZE059770-1182-BZE05972026-07-07
D745701182BZE06000BruxZir®70-1182-BZE060070-1182-BZE06002026-07-07
D745701182BZE06120BruxZir®70-1182-BZE061270-1182-BZE06122026-07-07
D745701182BZE06130BruxZir®70-1182-BZE061370-1182-BZE06132026-07-07
D745701182BZE06140BruxZir®70-1182-BZE061470-1182-BZE06142026-07-07
D745701182BZE06150BruxZir®70-1182-BZE061570-1182-BZE06152026-07-07
D745701182BZE06180BruxZir®70-1182-BZE061870-1182-BZE06182026-07-07
D745701182BZE06300BruxZir®70-1182-BZE063070-1182-BZE06302026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543674IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543681IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543698IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543704IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543711IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543728IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543735IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543858IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543865IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543872IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543889IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543902IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544053IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544060IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544077IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544084IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544091IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544213IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544220IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544237IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544244IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544251IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544268IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544275IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07