510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891338Substantially Equivalent

Smylon (Dental Stain Eraser)

The Smylon Co., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891338 is the FDA 510(k) clearance record for SMYLON (DENTAL STAIN ERASER), a class I device, cleared for The Smylon Co. on under FDA product code MAU (Eraser, Dental Stain). FDA records list one 510(k) clearance for The Smylon Co. As of , FDA records show no recalls naming K891338.

Clearance record

Decision date
Received
(246 days to decision)
Product code
MAU Eraser, Dental Stain
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
The Smylon Co. 7366 Waring Ave., Los Angeles CA
Third party review
No

Clearances, product code MAU

Trailing 12 months

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

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