Cleared Traditional

Vista BC Sealer (K221811) - FDA 510(k) Clearance

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

K221811 · Inter-Med, Inc. · Dental device
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Nov 2022
Decision
152d
Days
Class 2
Risk

K221811 is an FDA 510(k) clearance for the Vista BC Sealer. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on November 21, 2022 after a review of 152 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 Inter-Med, Inc. devices

Submission Details

510(k) Number K221811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date November 21, 2022
Days to Decision 152 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 127d · This submission: 152d
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 K221811.
SmartMTA Capsule
K230797 · Sprig Oral Health Technologies, Inc. · Mar 2023
Endocem MTA Premixed Regular
K213757 · Maruchi · Feb 2023
iRoot BP Root Repair Material BioAggregate Paste
K222992 · Innovative Bioceramix, Inc. · Nov 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
K212563 · Prevest Denpro Limited · May 2022
Injectable Root Canal Bioceramic Sealer
K212983 · Beijing C-Root Dental Medical Devices Co., Ltd. · Dec 2021
UltraCal XS
K211905 · Ultradent Products, Inc. · Oct 2021