FDA.reportPublic FDA data

Vericore ZR PRO

Primary DI
D040743281
Brand
Vericore ZR PRO
Company
WHIP-MIX CORPORATION
Model
74328
Device description
Vericore Zirconia blanks are made from pre-sinteredzirconium dioxide intended to be used with CAD/CAMor manual milling machines. Vericore zirconia blanksare biocompatible and designed to fabricate zirconiastructures.
Published
2020-02-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142670000Vericore Zirconia BlanksWhip Mix Corporation2014-10-22EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D040743281PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006385173
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D04071079C1Surgical Guide for Carbon71079-C2021-06-07
D040711751Veriguide OS71175711752020-09-22
D040600001ARDENT600002025-11-05
D040600011ARDENT600012025-11-05
D040600071ARDENT600072025-11-05
D040600081ARDENT 600082023-10-27
D040602061ARDENT 602062023-10-27
D040600021ARDENT DISPOSABLE DENT600022023-08-18
D040600031ARDENT DISPOSABLE DENT600032023-08-18
D040603000Forceps- Paper603002023-08-18
D0406010072Articulating paper/film60100601002020-08-24
D0406010160Articulating paper/film60101601012020-08-24
D0406020075Articulating paper/film60200602002020-08-24
D0406020175Articulating paper/film60201602012020-08-24
D0406020275Articulating paper/film60202602022020-08-24
D04060002140Articulating paper/film60002600022020-08-17
D04060003140Articulating paper/film60003600032020-08-17
D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
D04060006144Articulating paper/film60006600062020-08-17

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