510(k) Report

510(k) · Cleared

Cleared

Snowpost, Snowlight

K012354510(k) TraditionalCleared Oct 10, 200177-day reviewClass I21 CFR 872.3810

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

Danville Materials, Inc. · ELR Post, Root Canal

Cleared on Oct 10, 2001 as substantially equivalent to K945370 (Bisco, Inc., 1995) and 3 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Oct 10, 2001
Review
77 days
Class
Class I
Product code
ELR
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K945370 (1995). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1998: 1 other ancestor2002: 1 descendant cleared2006: 1 descendant clearedK945370 · C-POST · Bisco, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants K945370 · C-POST · Bisco, Inc. · 19950
  1. Root · 1 generation backK945370 C-POSTBisco, Inc. · 1995
  2. This deviceK012354 Snowpost, SnowlightDanville Materials, Inc. · 2001
  3. Descendant · cites it directly · 1 of its ownK020431 FibiocoreEst. Anthogyr · 2002
  4. Descendant · cites it directly · 0 of its ownK060075 Fiber-Metal PostForemost Dental, LLC · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K020431FibiocoreEst. Anthogyr · 2002 · cites it directly1descendant
  • K060075Fiber-Metal PostForemost Dental, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945370C-POSTBisco, Inc.1995—
0 (this device)K012354Snowpost, SnowlightDanville Materials, Inc.2001—
+1K020431FibiocoreEst. Anthogyr2002—
+1K060075Fiber-Metal PostForemost Dental, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
FIG. 1 — Lineage of K012354, 1995–2006Source: 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 ELR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

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
*K945370C-POST
Summary page 1
…Regulation Number Classification Name 972.3810 Dental root canal post The modified device is substantially equivalent to the previously cleared Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post (K003221) devic…
Bisco, Inc.1995—
*K000311Parapost Fiber White
Summary page 1
…2.3810 Dental root canal post The modified device is substantially equivalent to the previously cleared Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post (K003221) devices. The primary differences are minor c…
Coltene/Whaledent, Inc.2000—
*K983266Fibrekor Post System
Summary page 1
…ed device is substantially equivalent to the previously cleared Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post (K003221) devices. The primary differences are minor changes to the material and dimensions. T…
Jeneric/Pentron, Inc.1998—
*K003221Harald Nordin Glassix Glass Fiber Composite Dental Post
Summary page 1
…he previously cleared Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and Harald Nordin Glassix post (K003221) devices. The primary differences are minor changes to the material and dimensions. The modified device has the same intended u…
Harald Nordin S.A2000—

Also cleared against K945370: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K020431FibiocoreEst. Anthogyr20021
K060075Fiber-Metal PostForemost Dental, LLC20060

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K020431 (Est. Anthogyr, 2002) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K945370.

How does its category compare?

All ELR devices

ELR Post, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELR

FDA has decided no ELR device since 2007.

Median 510(k) review, days · ELR

Too few ELR 510(k)s in any year since 2007 to give a median.

Recalls per year · ELR

1in 2018

2009: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · ELR

1in 2025

2007: 82008: 52009: 32010: 12011: 42012: 132013: 62014: 302015: 32016: 82017: 12018: 52019: 202020: 22021: 32022: 22024: 12025: 1
2007high 30 (2014) · low 0 (2023)2025

MAUDE reports naming product code ELR, 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
20070—08
20080—05
20090—13
20100—01
20110—04
20120—013
20130—06
20140—030
20150—03
20160—08
20170—01
20180—15
20190—020
20200—02
20210—03
20220—02
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

Snowpost & Snowlight posts are indicated for use wherever root canal posts are required

and where esthetic considerations and/or where known metal allergies are of concern.

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 K945370

1 other device cites the same predicate.

  • K020431FibiocoreEst. Anthogyr · 2002

More from Danville Materials, Inc.

11 FDA decisions under this applicant name. See the company

  • K121880DMRC Nanoflow DMRC Nanocomposite Ebond Sure Etch Gel Sure Etch LiquidDanville Materials, Inc. · 2012
  • K111876Z Bond, Prelude OneDanville Materials, Inc. · 2011
  • K110642Siljetr SystemDanville Materials, Inc. · 2011
  • K102753Turbo Temp 3Danville Materials, Inc. · 2011
  • K092912Starfill 2B HV (High Viscosity) Rockcore, Model: 90838 and Starfill 2B LV (Low Viscosity), Model: 90150Danville Materials, Inc. · 2009

Recent decisions in ELR

The ELR category page

  • K060075Fiber-Metal PostForemost Dental, LLC · 2006
  • K042848FRC Postec PlusIvoclar Vivadent, Inc. · 2004
  • K030820Everstick PostStick Tech, Ltd. · 2003
  • K020431FibiocoreEst. Anthogyr · 2002
  • K012496Carbon PostJ. Morita USA, Inc. · 2002

https://510kreport.com/device/K012354 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012354: Snowpost, Snowlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012354

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026