FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

Vericore Zirconia Blanks

K Number: K142670 · Decision Oct 22, 2014
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
4
Review Days
33

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Basic Information

Device Name
Vericore Zirconia Blanks
K Number
K142670
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
872.6660
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Whip Mix Corporation
Date Received
September 19, 2014
Decision Date
October 22, 2014
Product Code
EIH
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EIH Powder, Porcelain

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Other Clearances by Whip Mix Corporation

K Number Device Name
K241729 Hard Splint & Thermo-Adaptive Splint
K190107 VeriSplint
K152443 Vericore Gradient Temporary Disc