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
SUBSCRIBE / SIGN IN
K864976Substantially Equivalent

Soluset Calcium Demineralizing Solution

Endo Technic Corp., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864976 is the FDA 510(k) clearance record for SOLUSET CALCIUM DEMINERALIZING SOLUTION, a class I device, cleared for Endo Technic Corp. on under FDA product code EKS (File, Pulp Canal, Endodontic). FDA records list 10 510(k) clearances for Endo Technic Corp., from to . As of , FDA records show no recalls naming K864976.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EKS File, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Endo Technic Corp. One Apple Hill Suite 316, Natick MA
Third party review
No

Clearances, product code EKS

Trailing 12 months

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

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