Cleared Traditional

K091632 - SPK SEALANT

K091632 is an FDA 510(k) clearance for SPK SEALANT, manufactured by 3M Company. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K091632 · 3M Company · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
91d
Days
Class 2
Risk

K091632 is an FDA 510(k) clearance for the SPK SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 91 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.

FDA 510(k) Submission Details - K091632

510(k) Number K091632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2009
Decision Date September 03, 2009
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
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 126
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K091632.
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K093059 · Classone Orthodontics, Inc. · Feb 2010
CLEAR BRAVO
K083473 · Denali R&D Corporation · Jan 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008
AURALAY PIT & FISSURE SEALANT
K071158 · Denali Corporation · Jun 2007
K091632 · SPK SEALANT
Download PDF FDA Summary 3M Company