510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895508Substantially Equivalent

Calasept Paste

Js Dental Mfg., Inc., Ridgefield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895508 is the FDA 510(k) clearance record for CALASEPT PASTE, a class II device, cleared for Js Dental Mfg., Inc. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list one 510(k) clearance for Js Dental Mfg., Inc. As of , FDA records show no recalls naming K895508.

Clearance record

Decision date
Received
(88 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Js Dental Mfg., Inc. P.O. Box 904, Ridgefield CT
Third party review
No

Clearances, product code EJK

Trailing 12 months
2 clearances under product code EJK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260