510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K992727Substantially Equivalent

The Bi-Directional Spiral & Epoxy Root Canal Cement System

Mds, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992727 is the FDA 510(k) clearance record for THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM, a class II device, cleared for Mds on under FDA product code KIF (Resin, Root Canal Filling). FDA records list one 510(k) clearance for Mds. As of , FDA records show no recalls naming K992727.

Clearance record

Decision date
Received
(158 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Mds 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260