510(k) · Cleared

Cleared

Kavo Everest C-Temp

K063624510(k) TraditionalCleared Feb 8, 200764-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

Kavo America · EBG Crown And Bridge, Temporary, Resin

Cleared on Feb 8, 2007 as substantially equivalent to K032081 (Kavo America, 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 2002.

Decided: Feb 8, 2007
Review: 64 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K022996 (2002). 4 ancestors in all, the oldest K001799 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
1 generation backK032081 Kavo Everest ZS-Blank Models, 42, 20, and 60Kavo America · 2003
This deviceK063624 Kavo Everest C-TempKavo America · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K022996	Vita in-Ceram YZ Cubes for Cerec	Vident	2002	—
−1	K032081	Kavo Everest ZS-Blank Models, 42, 20, and 60	Kavo America	2003	—
0 (this device)	K063624	Kavo Everest C-Temp	Kavo America	2007	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K063624, 2002–2007Source: 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? (2)

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
*	K032081	Kavo Everest ZS-Blank Models, 42, 20, and 60 Summary page 1 …shade, resin 21 CFR 872.3690 Class II medical device Product Code: EBF Panel: 76 Predicate devices: KaVo Everest® ZS K032081 and Austenal DC-Tell (K001799). Device description: The KaVo Everest® C-temp is a pre-formed material for use by…	Kavo America	2003	—
*	K001799	DC-Tell Summary page 1 …1 CFR 872.3690 Class II medical device Product Code: EBF Panel: 76 Predicate devices: KaVo Everest® ZS K032081 and Austenal DC-Tell (K001799). Device description: The KaVo Everest® C-temp is a pre-formed material for use by dental laboratories…	Austenal, Inc.	2000	—

Also cleared against K032081: 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)

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 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K032081.

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. 2007, 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 KaVo Everest® C-temp is used in the manufacture of temporary dental

prosthetics to be worn 12 months or less.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063624 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063624: Kavo Everest C-Temp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063624

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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