510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101814Substantially Equivalent

Direct Crown Natural 1

Candulor USA, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K101814 is the FDA 510(k) clearance record for DIRECT CROWN NATURAL 1, a class II device, cleared for Candulor USA, Inc. on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 2 510(k) clearances for Candulor USA, Inc., from to . As of , FDA records show no recalls naming K101814.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Candulor USA, Inc. 7462 N. Figueroa St., Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code EBG

Trailing 12 months
2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260