510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K191631Substantially Equivalent

ZMAXX Dental Zirconia Blanks

Zmaxx Bioceramics, LLC, Foster CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191631 is the FDA 510(k) clearance record for ZMAXX Dental Zirconia Blanks, a class II device, cleared for Zmaxx Bioceramics, LLC on under FDA product code EIH (Powder, Porcelain). FDA records list one 510(k) clearance for Zmaxx Bioceramics, LLC. As of , FDA records show no recalls naming K191631.

Clearance record

Decision date
Received
(135 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Zmaxx Bioceramics, LLC 231 Pelican Ct., Foster CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIH

Trailing 12 months
13 clearances under product code EIH in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20260