Cleared Traditional

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + (K240446) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240446 · Shiva Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
166d
Days
Class 2
Risk

K240446 is an FDA 510(k) clearance for the Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealm.... Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Shiva Products (Palghar, IN). The FDA issued a Cleared decision on July 30, 2024 after a review of 166 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shiva Products devices

Submission Details

510(k) Number K240446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2024
Decision Date July 30, 2024
Days to Decision 166 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K240446.
VioSeal
K242702 · Spident Co., Ltd. · Nov 2024
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · Longly Biotechnology (Wuhan) Co., Ltd. · Oct 2024
Vista BC Putty
K241457 · Inter-Med, Inc. · Aug 2024
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
K240304 · Enpuno Biotechnology Co., Ltd. · May 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · Beijing C-Root Dental Medical Devices Co., Ltd. · May 2024
One-Fil
K232182 · Mediclus Co., Ltd. · Jan 2024