510(k) Report

510(k) · Cleared

Cleared

Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)

K123653510(k) TraditionalCleared Jun 3, 2013188-day reviewClass II21 CFR 872.3260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bisco, Inc. · LBH Varnish, Cavity

Cleared on Jun 3, 2013 as substantially equivalent to K033521 (Bisco, Inc., 2004) and 2 other predicates after a 188-day review. Its family tree reaches back 3 generations to 2003.

Decided
Jun 3, 2013
Review
188 days
Class
Class II
Product code
LBH
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K030922 (2003). 6 ancestors in all, the oldest K983477 (1998). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors1998: 1 other ancestorK030922 · Vivasens · Ivoclar Vivadent, Inc. · 2003K050486 · Protect Tooth Desensitizer · Sunstar Butler · 2005K120109 · Super Seal Tooth Desensitizer · Phoenix Dental, Inc. · 201219952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K120109 · Super Seal Tooth Desensitizer · Phoenix Dental, Inc. · 2012K050486 · Protect Tooth Desensitizer · Sunstar Butler · 2005K030922 · Vivasens · Ivoclar Vivadent, Inc. · 20030
  1. Root · 3 generations backK030922 VivasensIvoclar Vivadent, Inc. · 2003
  2. 2 generations backK050486 Protect Tooth DesensitizerSunstar Butler · 2005
  3. 1 generation backK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
  4. This deviceK123653 Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K030922VivasensIvoclar Vivadent, Inc.2003—
−2K050486Protect Tooth DesensitizerSunstar Butler2005—
−1K120109Super Seal Tooth DesensitizerPhoenix Dental, Inc.2012—
0 (this device)K123653Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized)Bisco, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200420
FIG. 1 — Lineage of K123653, 2003–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LBH device

  1. #1 K262243 Profisil Freescore 12.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K033521Bisblock
Summary page 1
…H Classification/Name: Varnish, Cavity Class Il per 21 CFR 872.3260 Predicate Devices: Seal Block is substantially equivalent to: BisBlock by Bisco, Inc. Schaumburg IL K033521 Super Seal by Phoenix Dental, Inc. Fenton, Mi K983477 Super Seal Tooth Desensitizer by Phoenix Dental, Inc. Fenton, MI K120109 I…
Bisco, Inc.2004—
*K983477Super Seal
Summary page 1
…1 CFR 872.3260 Predicate Devices: Seal Block is substantially equivalent to: BisBlock by Bisco, Inc. Schaumburg IL K033521 Super Seal by Phoenix Dental, Inc. Fenton, Mi K983477 Super Seal Tooth Desensitizer by Phoenix Dental, Inc. Fenton, MI K120109 Indications for Use Seal Block PRO Version: The indica…
Phoenix Dental, Inc.1998—
*K120109Super Seal Tooth Desensitizer
Summary page 1
…to: BisBlock by Bisco, Inc. Schaumburg IL K033521 Super Seal by Phoenix Dental, Inc. Fenton, Mi K983477 Super Seal Tooth Desensitizer by Phoenix Dental, Inc. Fenton, MI K120109 Indications for Use Seal Block PRO Version: The indication for' usé of Seal Block PRO is to relieve sensitive teeth. Seal Bloc…
Phoenix Dental, Inc.2012—

Also cleared against K033521: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K033521.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LBH

4in 2025

2007: 82008: 62009: 42010: 72011: 32012: 42013: 62014: 62015: 22016: 22019: 22020: 52022: 12023: 32024: 32025: 42026 (partial year): 5
2007high 8 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBH

223in 2025

2007: 69 days median2008: 79 days median2009: 69 days median2010: 107 days median2011: 72 days median2012: 83 days median2013: 160 days median2014: 204 days median2020: 256 days median2023: 167 days median2024: 237 days median2025: 223 days median2026 (partial year): 64 days median
2007high 256 (2020) · low 69 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBH

1in 2019

2014: 32018: 22019: 1
2007high 3 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBH

7in 2025

2007: 42008: 32009: 52010: 72011: 82012: 72013: 272014: 402015: 142016: 122017: 112018: 132019: 92020: 102021: 152022: 72023: 82024: 62025: 7
2007high 40 (2014) · low 3 (2008)2025

MAUDE reports naming product code LBH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200786904
200867903
200946905
2010710707
201137208
201248307
20136160027
20146204340
20152—014
20162—012
20170—011
20180—213
20192—19
20205256010
20210—015
20221—07
2023316708
2024323706
2025422307
20265640—

What is it indicated for?

The indication for use of Seal Block PRO is to relieve sensitive teeth.

Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by:

Hot

Cold

Sweet

Acidic

Dental whitening agents

Seal Block PRO can also be used to relieve sensitivity:

Prior to temporization (placement of provisional restorations).

Prior to permanent cementation of indirect restorations.

Prior to placement of direct restorations.

When root surfaces are exposed.

Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K033521

1 other device cites the same predicate.

  • K120176Senzzzzz AwayCentrix, Inc. · 2012

More from Bisco, Inc.

88 FDA decisions under this applicant name. See the company

  • K250156Choice 2 DCBisco, Inc. · 2025
  • K242816QuantiumBisco, Inc. · 2024
  • K192007TheraBase, TheraBase CaBisco, Inc. · 2020
  • K182917FluoroCalBisco, Inc. · 2019
  • K180344TheraCal DCBisco, Inc. · 2018

Recent decisions in LBH

The LBH category page

  • K262243Profisil FreeKettenbach GmbH & Co. KG · 2026
  • K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026
  • K252073VOCO Profluorid Varnish + BioMinVoco GmbH · 2026
  • K261404UltraEZUltradent Products, Inc. · 2026
  • K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd. · 2026

https://510kreport.com/device/K123653 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123653: Seal Block Pro (Not Finalized), Seal Block Otc (Not Finalized).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123653

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026