Cleared Traditional

K240446 - Calx-O

K240446 is an FDA 510(k) clearance for Calx-O, manufactured by Shiva Products. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K240446

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.

KIF Device Classification - Class 2, Special Controls

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 83
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