Cleared Traditional

HELIOSEAL CLEAR CHROMA (K011491) - FDA 510(k) Clearance

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

K011491 · Ivoclar North America, Inc. · Dental device
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Aug 2001
Decision
93d
Days
Class 2
Risk

K011491 is an FDA 510(k) clearance for the HELIOSEAL CLEAR CHROMA. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K011491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date August 16, 2001
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 25
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K011491.
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018
HAPI Seal
K162598 · Bisco, Inc. · May 2017
SPK SEALANT
K091632 · 3M Company · Sep 2009
NRC NON-RINSE CONDITIONER
K992519 · Dentsply Intl. · Oct 1999
3M CLINPRO SEALANT
K992326 · 3M Company · Oct 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518 · Dentsply Intl. · Sep 1999