510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913168Substantially Equivalent

Salibag

Nix Co., Ltd., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913168 is the FDA 510(k) clearance record for SALIBAG, a class I device, cleared for Nix Co. , Ltd. on under FDA product code EGZ (Holder, Film, X-Ray). FDA records list 2 510(k) clearances for Nix Co. , Ltd. As of , FDA records show no recalls naming K913168.

Clearance record

Decision date
Received
(51 days to decision)
Product code
EGZ Holder, Film, X-Ray
Regulation
21 CFR 872.1905
Device class
Class I
Review panel
Dental
Applicant
Nix Co. , Ltd. C/O Meadox Consulting Services, Oakland NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EGZ

Trailing 12 months

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

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