510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K931162Substantially Equivalent

King-Hue, Royal Coral, Super-C Artificial Teeth

King Dental Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931162 is the FDA 510(k) clearance record for KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH, a class II device, cleared for King Dental Corp. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list 2 510(k) clearances for King Dental Corp., from to . As of , FDA records show no recalls naming K931162.

Clearance record

Decision date
Received
(80 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
King Dental Corp. 10544 NW 26th St.,, Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code ELM

Trailing 12 months

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

FDA records show no clearances under product code ELM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELM, 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