Cleared Traditional

HELIOSEAL CLEAR CHROMA

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

About This 510(k) Submission

K011491 is an FDA 510(k) clearance for the HELIOSEAL CLEAR CHROMA, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on August 16, 2001, 93 days after receiving the submission on May 15, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K011491 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — EBC Sealant, Pit And Fissure, And Conditioner

All 129
Parkell Pit and Fissure Sealant
K243254 · Parkell, Inc. · Aug 2025
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 2023
Enamel Coating Resin
K230455 · Rizhao Huge Biomaterials Company, Ltd. · Jul 2023
BA Pit & Fissure Sealant
K190998 · Apex Dental Materials, Inc. · Nov 2019
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018