510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K832378Substantially Equivalent

Vibratory Endodontic System

Syntex Dental Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832378 is the FDA 510(k) clearance record for VIBRATORY ENDODONTIC SYSTEM, a class I device, cleared for Syntex Dental Products, Inc. on under FDA product code EKQ (Preparer, Root Canal Endodontic). FDA records list 3 510(k) clearances for Syntex Dental Products, Inc., from to . As of , FDA records show no recalls naming K832378.

Clearance record

Decision date
Received
(77 days to decision)
Product code
EKQ Preparer, Root Canal Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Syntex Dental Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EKQ

Trailing 12 months

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

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