510(k) clearances

Zirconia Collective 4Y Dental Zirconia Blank

Zirconia Collective, Inc. · Dental

K262685Substantially EquivalentTraditionalEIH
Open FDA's page for this record
Third party flag
N
City
Westminster
Advisory committee description
Dental
Address 1
10860 Dover St.
Address 2
Suite 2500
Statement or summary
Summary
Product code
EIH
Zip code
80021
Applicant
Zirconia Collective, Inc.
Decision date
2026-10-30
Decision code
SESE
Country code
US
Device name
Zirconia Collective 4Y Dental Zirconia Blank
Advisory committee
DE
Contact
Gerard Giuliano Jr
K number
K262685
State
CO
Date received
2026-07-31
Review advisory committee
DE
Postal code
80021
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powder, Porcelain
Medical specialty description
Dental
Regulation number
872.6660
Device class
2
Registration number
2018957, 3017450159, 3031595584, 1420052, 2647456, 3008912871, 3025436468, 3011824442, 9613953, 3013551048, 2082832, 3034244245, 1725006, 9612618, 3018249917, 9612352, 3006235664, 3012187973, 3008578884, 3008347275, 3027481489, 3003310824, 3003775534, 3045855232, 3027341558, 3009727738, 3007160911, 8031058, 3009496224, 2244842, 3012441963, 3022068322, 3032163716, 3006223010, 1000118628, 3009312656, 3006146796, 3040605150, 3038718579, 3004491043 +124 more
FEI number
2018957, 3017450159, 3031595584, 1420052, 2647456, 3008912871, 3025436468, 3011824442, 3013551048, 2082832, 3034244245, 3018249917, 3006235664, 3012187973, 1000269600, 3008578884, 3008347275, 3002809338, 3027481489, 3003310824, 3003775534, 3045855232, 3027341558, 3009727738, 3007160911, 3002806651, 3009496224, 2244842, 3012441963, 3022068322, 3032163716, 3006223010, 1000118628, 3009312656, 3006146796, 3040605150, 3038718579, 3004491043, 3008254125, 3009740550 +124 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.