Cleared Traditional

K161580 - Premier Sealant

K161580 is an FDA 510(k) clearance for Premier Sealant, manufactured by Premier Dental Company Products. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K161580 · Premier Dental Company Products · Dental device
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Oct 2016
Decision
132d
Days
Class 2
Risk

K161580 is an FDA 510(k) clearance for the Premier Sealant. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Premier Dental Company Products (Plymouth Meeting, US). The FDA issued a Cleared decision on October 18, 2016 after a review of 132 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 Premier Dental Company Products devices

FDA 510(k) Submission Details - K161580

510(k) Number K161580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2016
Decision Date October 18, 2016
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K161580.
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018
Nanova Sealant
K171330 · Nanova Biomaterials, Inc. · Sep 2017
HAPI Seal
K162598 · Bisco, Inc. · May 2017
PACSEAL PIT & FISSURE SEALANT
K141717 · Pac-Dent International, Inc. · Mar 2015
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
PREVENT SEAL
K122521 · Itena Clinical · Jun 2013