510(k) Report

510(k) · Cleared

Cleared

Fluoroseal, Dentin Sealer and Cavity Liner

K860633510(k) TraditionalCleared Apr 11, 198650-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

Scientific Pharmaceuticals, Inc. · LBH Varnish, Cavity

Cleared on Apr 11, 1986 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 11, 1986
Review
50 days
Class
Class II
Product code
LBH
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK860633 Fluoroseal, Dentin Sealer and Cavity LinerScientific Pharmaceuticals, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK113711 Lime-Lite IIPulpdent Corporation · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K113711Lime-Lite IIPulpdent Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860633Fluoroseal, Dentin Sealer and Cavity LinerScientific Pharmaceuticals, Inc.1986—
+1K113711Lime-Lite IIPulpdent Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K860633, 1986–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113711Lime-Lite IIPulpdent Corporation20120

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?

  • Of its descendants, K113711 (Pulpdent Corporation, 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Scientific Pharmaceuticals, Inc.

72 FDA decisions under this applicant name. See the company

  • K051952EugenoneScientific Pharmaceuticals, Inc. · 2005
  • K041886ProvisoScientific Pharmaceuticals, Inc. · 2004
  • K013555Sci-Pharm Post SecureScientific Pharmaceuticals, Inc. · 2002
  • K001446Light-Cured Orthodontic Band CementScientific Pharmaceuticals, Inc. · 2000
  • K993324Carbocem Zinc Polycarboxylate CementScientific Pharmaceuticals, Inc. · 1999

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/K860633 · printed Nov 5, 2026

Cite this page

510(k) Report. “K860633: Fluoroseal, Dentin Sealer and Cavity Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K860633

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026