Cleared Traditional

K162598 - HAPI Seal

K162598 is the FDA 510(k) clearance for HAPI Seal by Bisco, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K162598 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
246d
Days
Class 2
Risk

K162598 is an FDA 510(k) clearance for the HAPI Seal. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on May 23, 2017 after a review of 246 days - an extended review cycle.

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 Bisco, Inc. devices

Submission Details

510(k) Number K162598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date May 23, 2017
Days to Decision 246 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
119d slower than avg
Panel avg: 127d · This submission: 246d
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 52
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K162598.
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
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010