510(k) · Cleared

Recalled · 2009

Flex Span Temporary Crown & Bridge Material

K021457510(k) TraditionalCleared Aug 1, 200287-day reviewClass II21 CFR 872.3770Recalls 1

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

Pentron Corp. · EBG Crown And Bridge, Temporary, Resin

Cleared on Aug 1, 2002 as substantially equivalent to K020092 (Kerr Dental Materials Center, 2002) after an 87-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.

Decided: Aug 1, 2002
Review: 87 days
Class: Class II
Product code: EBG
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K020092 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK020092 TemphaseKerr Dental Materials Center · 2002
This deviceK021457 Flex Span Temporary Crown & Bridge MaterialPentron Corp. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020092	Temphase	Kerr Dental Materials Center	2002	—
0 (this device)	K021457	Flex Span Temporary Crown & Bridge Material	Pentron Corp.	2002	—

FIG. 1 — Lineage of K021457, 2002–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EBG? 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 EBG device

#1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K020092	Temphase Summary page 1 …permanent restoration is fabricated. We believe that Flex Span Temporary Crown & Bridge Material is substantially equivalent to Sybron Dental Specialties, Inc. Temphase, K020092. Flcxspan Temporary Crown and Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the c…	Kerr Dental Materials Center	2002	—

Also cleared against K020092: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 22, 2009	Not classified	Z-0482-2010	Employee error	Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K020092.

How does its category compare?

All EBG devices

EBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBG

4in 2025

2007high 14 (2020) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBG

106in 2025

2007high 265 (2021) · low 64 (2007)2026

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

Recalls per year · EBG

1in 2020

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EBG

1in 2025

2007high 26 (2015) · low 0 (2018)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	64	0	4
2008	9	83	0	4
2009	2	—	1	1
2010	5	103	0	1
2011	10	96	0	1
2012	5	90	0	5
2013	2	—	0	11
2014	3	114	0	23
2015	6	209	0	26
2016	4	163	0	8
2017	2	—	0	4
2018	4	202	0	0
2019	6	98	0	6
2020	14	194	1	2
2021	3	265	0	4
2022	3	73	0	2
2023	2	—	0	0
2024	5	144	0	0
2025	4	106	0	1
2026	2	—	0	—

What is it indicated for?

Flex Span Temporary Crown & Bridge Material is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021457 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021457: Flex Span Temporary Crown & Bridge Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021457

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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