510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080146Substantially Equivalent

Zirkondent

Ergometa, Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080146 is the FDA 510(k) clearance record for ZIRKONDENT, a class II device, cleared for Ergometa on under FDA product code EIH (Powder, Porcelain). FDA records list one 510(k) clearance for Ergometa. As of , FDA records show no recalls naming K080146.

Clearance record

Decision date
Received
(136 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Ergometa 144 Los Flores, Aliso Viejo CA
510(k) summary
Statement
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