510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932759Substantially Equivalent

Tempoary Polycarbonate Crowns

South American Dental Exporting Corp., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932759 is the FDA 510(k) clearance record for TEMPOARY POLYCARBONATE CROWNS, a class I device, cleared for South American Dental Exporting Corp. on under FDA product code ELZ (Crown, Preformed). FDA records list one 510(k) clearance for South American Dental Exporting Corp. As of , FDA records show no recalls naming K932759.

Clearance record

Decision date
Received
(409 days to decision)
Product code
ELZ Crown, Preformed
Regulation
21 CFR 872.3330
Device class
Class I
Review panel
Dental
Applicant
South American Dental Exporting Corp. 1058 E. 33rd St., Hialeah FL
510(k) summary
Statement
Third party review
No

Clearances, product code ELZ

Trailing 12 months

FDA records hold no clearances under product code ELZ in the trailing twelve months.

FDA records show no clearances under product code ELZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260