Cleared Traditional

K091632 - SPK SEALANT

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

K091632 · 3M Company · Dental device
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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.

View all 3M Company devices

Submission Details

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
36d faster than avg
Panel avg: 127d · This submission: 91d
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 60
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K091632.
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · Premier Dental Products Co. · Oct 2006
GRANDIO SEAL
K062344 · Voco GmbH · Oct 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823 · Voco GmbH · Jul 2006