510(k) Report

510(k) · Cleared

Cleared

Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505

K080249510(k) SpecialCleared Feb 8, 20088-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

Ultradent Products, Inc. · LBH Varnish, Cavity

Cleared on Feb 8, 2008 as substantially equivalent to K051750 (Ultradent Products, Inc., 2005) after an 8-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it.

Decided
Feb 8, 2008
Review
8 days
Class
Class II
Product code
LBH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051750 (2005). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK051750 · Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 · Ultradent Products, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants K051750 · Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502 · Ultradent Products, Inc. · 20050
  1. Root · 1 generation backK051750 Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc. · 2005
  2. This deviceK080249 Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc. · 2008
  3. Descendant · cites it directly · 4 of its ownK132109 EnamelastUltradent Products Inc. / Oratech, LLC · 2013 · Recalled
  4. Descendant · cites it directly · 1 of its ownK112946 Activ VarnishPulpdent Corporation · 2011
  5. Descendant · 2 generations on · 0 of its ownK253052 Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026
  6. Descendant · 2 generations on · 0 of its ownK243777 Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry)…Theodent, LLC · 2025
  7. Descendant · 2 generations on · 0 of its ownK151302 Clinpro Varnish3M Company · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12014: 22015: 12025: 12026: 1
2011high 2 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K132109EnamelastUltradent Products Inc. / Oratech, LLC · 2013 · cites it directly4descendants
  • K112946Activ VarnishPulpdent Corporation · 2011 · cites it directly1descendant
  • K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd. · 2026 · 2 generations on0descendants
  • K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3%…Theodent, LLC · 2025 · 2 generations on0descendants
  • K151302Clinpro Varnish3M Company · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051750Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc.2005—
0 (this device)K080249Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505Ultradent Products, Inc.2008—
+1K132109EnamelastUltradent Products Inc. / Oratech, LLC20132
+1K112946Activ VarnishPulpdent Corporation2011—
+2K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.2026—
+2K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™…Theodent, LLC2025—
+2K151302Clinpro Varnish3M Company2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201420
201510
202510
202610
FIG. 1 — Lineage of K080249, 2005–2026Source: 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), 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 12.9 · 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? (1)

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
*K051750Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502
Summary page 1
…11 Classification Product Code: LBH Legally Marketed Predicate Devices to Which Equivalence is Claimed The predicate device isFlor-Opal Varnish (K051750) This device ismanufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Pro…
Ultradent Products, Inc.2005—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132109EnamelastUltradent Products Inc. / Oratech, LLC20134
K112946Activ VarnishPulpdent Corporation20111

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?

  • Its one ancestor has no recall.
  • Of its descendants, K132109 (Ultradent Products Inc. / Oratech, LLC, 2013) has gone furthest, with 4 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. 2008, 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?

Flor-Opal Varnish White is 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Indications for use as stated in the FDA summary.

More from Ultradent Products, Inc.

104 FDA decisions under this applicant name. See the company

  • K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026
  • K261404UltraEZUltradent Products, Inc. · 2026
  • K240743Peak Universal BondUltradent Products, Inc. · 2024
  • K240694FORMA Composite (Shade A3D)Ultradent Products, Inc. · 2024
  • K221909J-TempUltradent Products, Inc. · 2022

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/K080249 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080249: Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080249

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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