Cleared Traditional

K123653 - SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

K123653 is an FDA 510(k) clearance for SEAL BLOCK PRO (NOT FINALIZED), manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K123653 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
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Jun 2013
Decision
188d
Days
Class 2
Risk

K123653 is an FDA 510(k) clearance for the SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED). Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on June 3, 2013 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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

FDA 510(k) Submission Details - K123653

510(k) Number K123653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2012
Decision Date June 03, 2013
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 93
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K123653.
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
ALPHA-PRO WHITE VARNISH
K124025 · Dental Technologies, Inc. · Sep 2013
SMARTCOAT 2.5% NAF VARNISH
K131376 · Elevate Oral Care · Aug 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
REMESENSE FOR SENSITIVE TEETH
K122708 · Sylphar N.V. · Jan 2013
CAVITY VARNISH
K122331 · Dentsply International, Inc. · Oct 2012