FDA.reportPublic FDA data

BruxZir NOW

Primary DI
D745701167NOW00970
Brand
BruxZir NOW
Company
Prismatik Dentalcraft, Inc
Model
70-1167-NOW0097
Catalog number
70-1167-NOW0097
Device description
BruxZir NOW - C2
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K220816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220816000BruxZir NOWPrismatik Dentalcraft, Inc.2022-08-02EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701167NOW00971PrimaryHIBCC0
D745701167NOW00970Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
022761689
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701122OMB01611Obsidian70-1122-OMB016170-1122-OMB01612016-09-23
D74570BIOBGP050Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP0570-BIO-BGP052016-09-24
D74570BIOBGP100Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP1070-BIO-BGP102016-10-07
D74570BIOBGP200Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP2070-BIO-BGP202016-09-24
D745SN3D0Silent Nite 3D Sleep ApplianceSN3DSN3D2026-10-07
D745MAPCSDLA0Silent Nite 3D Sleep ApplianceMA-PC-SD-LAMA-PC-SD-LA2024-04-15
D745MAPCSDOP0Silent Nite 3D Sleep ApplianceMA-PC-SD-OPMA-PC-SD-OP2024-04-15
D745MAPCSDUA0Silent Nite 3D Sleep ApplianceMA-PC-SD-UAMA-PC-SD-UA2024-04-15
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.io70-1181-MIL046770-1181-MIL04672026-03-16
D745701072PRC00010Inclusive70-1072-PRC000170-1072-PRC00012015-10-24
D745701072PRC00580Inclusive70-1072-PRC005870-1072-PRC00582015-10-24
D745701173COM00040Inclusive70-1173-COM000470-1173-COM00042016-10-07
D745701122SHS01451Obsidian70-1122-SHS014570-1122-SHS01452016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817724020500Luxisse+HEANY INDUSTRIES, INC.EIH2019-12-23
00817724020326Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020333Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020340Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020357Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020364Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020371Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020388Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020395Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020401Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020418Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020425Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020432Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020449Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020456Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020463Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020470Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020487Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020494Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020036Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020043Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020050Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020067Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020074Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020081Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020098Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020104Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020111Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020128Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020135Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31