510(k) Report

510(k) · Cleared

Cleared

Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P

K030951510(k) TraditionalCleared Jun 6, 200372-day reviewClass II21 CFR 872.3690

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

Bisco, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Jun 6, 2003 after a 72-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Jun 6, 2003
Review
72 days
Class
Class II
Product code
EBF
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 2 descendants cleared2010: 2 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK030951 Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PBisco, Inc. · 2003
  2. Descendant · cites it directly · 5 of its ownK083051 Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009
  3. Descendant · 2 generations on · 0 of its ownK234043 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023
  4. Descendant · 2 generations on · 0 of its ownK130237 Pontic PaintReliance Orthodontic Products, Inc. · 2013
  5. Descendant · 2 generations on · 0 of its ownK123348 Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013
  6. Descendant · 2 generations on · 0 of its ownK101951 Light Cure RetainerReliance Orthodontic Products, Inc. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22013: 22023: 1
2009high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K083051Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009 · cites it directly5descendants
  • K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023 · 2 generations on0descendants
  • K130237Pontic PaintReliance Orthodontic Products, Inc. · 2013 · 2 generations on0descendants
  • K123348Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013 · 2 generations on0descendants
  • K101951Light Cure RetainerReliance Orthodontic Products, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030951Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PBisco, Inc.2003—
+1K083051Flowtain & Flowtain LVReliance Orthodontic Products, Inc.2009—
+2K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products2023—
+2K130237Pontic PaintReliance Orthodontic Products, Inc.2013—
+2K123348Clear Aligner AdhesiveReliance Orthodontic Products, Inc.2013—
+2K101951Light Cure RetainerReliance Orthodontic Products, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201320
202310
FIG. 1 — Lineage of K030951, 2003–2023Source: 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 EBF? 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 EBF device

  1. #1 K202846 Tera Harzscore 18.5 · 7 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
*—NTL-Flow
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K083051Flowtain & Flowtain LVReliance Orthodontic Products, Inc.20095

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, K083051 (Reliance Orthodontic Products, Inc., 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007: 192008: 142009: 202010: 192011: 192012: 112013: 132014: 102015: 172016: 202017: 152018: 152019: 172020: 152021: 132022: 172023: 92024: 182025: 152026 (partial year): 16
2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007: 49 days median2008: 79 days median2009: 84 days median2010: 75 days median2011: 81 days median2012: 86 days median2013: 153 days median2014: 112 days median2015: 123 days median2016: 205 days median2017: 108 days median2018: 115 days median2019: 159 days median2020: 190 days median2021: 178 days median2022: 63 days median2023: 87 days median2024: 120 days median2025: 43 days median2026 (partial year): 59 days median
2007high 205 (2016) · low 43 (2025)2026

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

Recalls per year · EBF

1in 2020

2007: 12008: 422009: 12010: 62011: 72017: 42019: 22020: 12026 (partial year): 2
2007high 42 (2008) · low 0 (2012)2026

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

Adverse event reports per year · EBF

1in 2025

2007: 62008: 102009: 82010: 312011: 312012: 622013: 2462014: 1952015: 1192016: 1432017: 422018: 82019: 112020: 22021: 22022: 22023: 82024: 52025: 1
2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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
2007194916
200814794210
2009208418
20101975631
20111981731
20121186062
2013131530246
2014101120195
2015171230119
2016202050143
201715108442
20181511508
201917159211
20201519012
20211317802
2022176302
202398708
20241812005
2025154301
202616592—

What is it indicated for?

1. Esthetic restorative material for Class 111, IV, and V.

2. Conservative Class I and Class I1 not involving opposing occlusal contact for direct or indirect use.

3. Direct Esthetic veneer restorative for masking stains and developmental anomalies.

4. Pit and fissure sealant.

5. Core buildup material to replace missing tooth structure.

6. Direct cementing agent and dental liner.

7. Indirect cement for use with reinforcement materials to fabricate crowns and bridges.

6. Composite/porcelain repair material.

Indications for use as stated in the FDA summary.

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 EBF

The EBF category page

  • K262982Core·it DualSpident Co., Ltd. · 2026
  • K262202Cerasmart ForteGC America, Inc. · 2026
  • K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd. · 2026
  • K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc. · 2026
  • K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026

https://510kreport.com/device/K030951 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030951: Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030951

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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