510(k) · Cleared

Cleared

Modified Temprx Esthetic Provisional System

K080311510(k) TraditionalCleared Apr 18, 200872-day reviewClass II21 CFR 872.3770

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

Dentsply Interntional · EBG Crown And Bridge, Temporary, Resin

Cleared on Apr 18, 2008 as substantially equivalent to K061264 (Dentsply International, Inc., 2006) after a 72-day review. Its family tree reaches back 2 generations to 1991.

Decided: Apr 18, 2008
Review: 72 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K904251 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK904251 New Triad VLC Crown & Bridge Provisional MaterialDentifax Intern, Inc. · 1991
1 generation backK061264 Tempfx Esthetic Provisional SystemDentsply International, Inc. · 2006
This deviceK080311 Modified Temprx Esthetic Provisional SystemDentsply Interntional · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K904251	New Triad VLC Crown & Bridge Provisional Material	Dentifax Intern, Inc.	1991	—
−1	K061264	Tempfx Esthetic Provisional System	Dentsply International, Inc.	2006	—
0 (this device)	K080311	Modified Temprx Esthetic Provisional System	Dentsply Interntional	2008	—

FIG. 1 — Lineage of K080311, 1991–2008Source: 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
*	K061264	Tempfx Esthetic Provisional System Summary page 1 …CLASSIFICATION NAME: Temporary Crown and Bridge Resin, EB3G, 872.3770 PREDICATE DEVICES: TempFx Esthetic Provisional System, K06 1264 DEVICE DESCRIPTION: The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessor…	Dentsply International, Inc.	2006	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
None of the 2 ancestors has a recall.

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. 2008, this device’s year, is highlighted.

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?

The Modified TempRx Esthetic Provisional System is:

· Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.

* Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:

· Inlays/ Onlays

* Veneers

* Crowns

* 3-unit bridges through the 2nd bicuspid.

* Indicated for the build up of a tooth on denture base resins.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080311: Modified Temprx Esthetic Provisional System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080311

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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