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
K955285Substantially Equivalent

Galloy

Southern Dental Industries, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955285 is the FDA 510(k) clearance record for GALLOY, a class II device, cleared for Southern Dental Industries, Inc. on under FDA product code EJJ (Alloy, Amalgam). FDA records list 24 510(k) clearances for Southern Dental Industries, Inc., from to . As of , FDA records show no recalls naming K955285.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Southern Dental Industries, Inc. 246 First St., Suite 204, San Francisco CA
510(k) summary
Statement
Third party review
No

Clearances, product code EJJ

Trailing 12 months

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

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