510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011338Substantially Equivalent

Oto-Cem

Ototech, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011338 is the FDA 510(k) clearance record for OTO-CEM, a class II device, cleared for Ototech, Inc. on under FDA product code NEA (Cement, Ear, Nose And Throat). FDA records list 5 510(k) clearances for Ototech, Inc., from to . As of , FDA records show no recalls naming K011338.

Clearance record

Decision date
Received
(134 days to decision)
Product code
NEA Cement, Ear, Nose And Throat
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Ototech, Inc. 1625 K St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code NEA

Trailing 12 months

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

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