510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K170050Substantially Equivalent

Z-CAD smile

Metoxit AG, Thayngen, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170050 is the FDA 510(k) clearance record for Z-CAD smile, a class II device, cleared for Metoxit AG on under FDA product code EIH (Powder, Porcelain). FDA records list 2 510(k) clearances for Metoxit AG, from to . As of , FDA records show no recalls naming K170050.

Clearance record

Decision date
Received
(595 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Metoxit AG Emdwiesenstrasse 6, Thayngen, CH
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