FDA.reportPublic FDA data

BruxZir

Primary DI
D745701155BXA00050
Brand
BruxZir
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1155-BXA0005
Catalog number
70-1155-BXA0005
Device description
BruxZir Anterior White 1-Pack 12mm Standard
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K143330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143330000BruxZir AnteriorPrismatik Dentalcraft, Inc.2014-12-15EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701155BXA00050PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)440-2629Shelly.Harris@glidewelldental.com

Regulatory Flags#

DUNS number
021228671
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701197FTD00010FinalTouch70-1197-FTD000170-1197-FTD00012022-09-14
D745701181MIL00160fastdesign.io70-1181-MIL001670-1181-MIL00162018-10-19
D745701047COM00580Inclusive70-1047-COM005870-1047-COM00582015-10-24
D745701155BXA00010BruxZir70-1155-BXA000170-1155-BXA00012016-09-23
D745701155BXA00030BruxZir70-1155-BXA000370-1155-BXA00032016-09-23
D745701155BXA00040BruxZir70-1155-BXA000470-1155-BXA00042016-09-23
D745701155BXA00060BruxZir70-1155-BXA000670-1155-BXA00062016-09-23
D745701155BXA00070BruxZir70-1155-BXA000770-1155-BXA00072016-09-23
D745701155BXA00080BruxZir70-1155-BXA000870-1155-BXA00082016-09-23
D745701155BXA00090BruxZir70-1155-BXA000970-1155-BXA00092016-09-23
D745701155BXA00100BruxZir70-1155-BXA001070-1155-BXA00102016-09-23
D745701155BXA00110BruxZir70-1155-BXA001170-1155-BXA00112016-09-23
D745701155BXA00120BruxZir70-1155-BXA001270-1155-BXA00122016-09-23
D745701155BXA00140BruxZir70-1155-BXA001470-1155-BXA00142016-09-23
D745701155BXA00150BruxZir70-1155-BXA001570-1155-BXA00152016-09-23
D745701155BXA00160BruxZir70-1155-BXA001670-1155-BXA00162016-09-23
D745701155BXA00170BruxZir70-1155-BXA001770-1155-BXA00172016-09-23
D745701155BXA00190BruxZir70-1155-BXA001970-1155-BXA00192016-09-23
D745701155BXA00210BruxZir70-1155-BXA002170-1155-BXA00212016-09-23
D745701155BXA00220BruxZir70-1155-BXA002270-1155-BXA00222016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01694207545069BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423619BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423626BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423633BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423640BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423657BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423664BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423671BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423688BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423695BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423701BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423718BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423725BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423732BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423749BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423756BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423763BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423770BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423787BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423794BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423800BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423817BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423824BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423831BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423848BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423855BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423862BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423879BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423886BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423893BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25