510(k) · Cleared

Cleared

MD-Temp

K061530510(k) TraditionalCleared Jul 21, 200649-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

Meta Biomed Co., Ltd. · EBG Crown And Bridge, Temporary, Resin

Cleared on Jul 21, 2006 as substantially equivalent to K033022 (3M Espe AG Dental Products, 2003) and 4 other predicates after a 49-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.

Decided: Jul 21, 2006
Review: 49 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K001114 (2000). 6 ancestors in all, the oldest K875133 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK001114 3M Quik Temp Temporization Material3M Company · 2000
1 generation backK033022 Protemp 3 Garant3M Espe AG Dental Products · 2003
This deviceK061530 MD-TempMeta Biomed Co., Ltd. · 2006
Descendant · cites it directly · 0 of its ownK190724 MD-Temp PlusMeta Biomed Co., Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all

K190724MD-Temp PlusMeta Biomed Co., Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001114	3M Quik Temp Temporization Material	3M Company	2000	—
−1	K033022	Protemp 3 Garant	3M Espe AG Dental Products	2003	—
0 (this device)	K061530	MD-Temp	Meta Biomed Co., Ltd.	2006	—
+1	K190724	MD-Temp Plus	Meta Biomed Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
2000	2	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K061530, 2000–2019Source: 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? (5)

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
*	K033022	Protemp 3 Garant Summary page 1 …MD-Temp is substantially equivalent to several temporary resins for tooth restoration currently on the market. These include (among others): "Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 an…	3M Espe AG Dental Products	2003	—
*	K024282	Acrylic Summary page 1 …uivalent to several temporary resins for tooth restoration currently on the market. These include (among others): "Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 and "Cavit-W," K875133. Physic…	Inovativ, LLC	2003	—
*	K002364	Protemp H Summary page 1 …mporary resins for tooth restoration currently on the market. These include (among others): "Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 and "Cavit-W," K875133. Physical properties, composi…	Espe Dental AG	2000	—
*	K001309	Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material, Model 98250 Summary page 1 …nclude (among others): "Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 and "Cavit-W," K875133. Physical properties, compositions, and use of MD-Tempt m are similar to predicate 510(k)s. The "5…	Kay See Dental Mfg. Co.	2000	—
*	K875133	Cavit-W Summary page 1 …"Protemp 3 Garant," K033022; "Acrylic," K024282; "Protemp H," K002364; "Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material," K001309 and "Cavit-W," K875133. Physical properties, compositions, and use of MD-Tempt m are similar to predicate 510(k)s. The "510(k) "Substantial Equi…	Espe GmbH (Us)	1988	—

Also cleared against K033022: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K190724	MD-Temp Plus	Meta Biomed Co., Ltd.	2019	0

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 6 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K190724 (Meta Biomed Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K033022.

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?

For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation.

Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061530 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061530: MD-Temp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061530

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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