510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060691Substantially Equivalent

Easy X-Trac System

A. Titan Instruments, Inc., Hamburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060691 is the FDA 510(k) clearance record for EASY X-TRAC SYSTEM, a class I device, cleared for A. Titan Instruments, Inc. on under FDA product code EMG (Forceps, Tooth Extractor, Surgical). FDA records list one 510(k) clearance for A. Titan Instruments, Inc. As of , FDA records show no recalls naming K060691.

Clearance record

Decision date
Received
(89 days to decision)
Product code
EMG Forceps, Tooth Extractor, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
A. Titan Instruments, Inc. 97 Main St., Hamburg NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EMG

Trailing 12 months

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

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