FDA.reportPublic FDA data

BruxZir

Primary DI
D745701185BXP05820
Brand
BruxZir
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1185-BXP0582
Catalog number
70-1185-BXP0582
Device description
BruxZir Shaded 16 PLUS GL Bridge Block - C3
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K130924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130924000BRUXZIR SHADEDPrismatik Dentalcraft, Inc.2013-05-16EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701185BXP05821PrimaryHIBCC0
D745701185BXP05820Unit 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
021228671
Device count
20
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
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
D745701155BXA00050BruxZir70-1155-BXA000570-1155-BXA00052016-09-23
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
D745701155BXA00240BruxZir70-1155-BXA002470-1155-BXA00242016-09-23

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Primary DI, Brand, Company table
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