510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083512Substantially Equivalent

Fluid-Filled Teether

Wiltec Industries, Ltd., Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083512 is the FDA 510(k) clearance record for FLUID-FILLED TEETHER, a class II device, cleared for Wiltec Industries , Ltd. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list 2 510(k) clearances for Wiltec Industries , Ltd., from to . As of , FDA records show no recalls naming K083512.

Clearance record

Decision date
Received
(147 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Wiltec Industries , Ltd. 5401 S Cottonwood Ct., Greenwood Village CO
510(k) summary
Statement
Third party review
No

Clearances, product code KKO

Trailing 12 months

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

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