510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202281Substantially Equivalent

EDS Bioceramic Sealer (Bioseal)

Essential Dental Systems, Inc., South Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202281 is the FDA 510(k) clearance record for EDS Bioceramic Sealer (Bioseal), a class II device, cleared for Essential Dental Systems on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 18 510(k) clearances for Essential Dental Systems, from to . As of , FDA records show no recalls naming K202281.

Clearance record

Decision date
Received
(184 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Essential Dental Systems 89 Leuning St., South Hackensack NJ
510(k) summary
Summary PDF
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