510(k) · Cleared

Cleared

C&B Resin Plus Powder/Liquid, Models Retemp A2, A3, A3.5, CL, Retemp B2, B3, C2, D3, WH, Retemp MO

K000894510(k) TraditionalCleared May 19, 200060-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

Dental Ventures of America, Inc. · EBG Crown And Bridge, Temporary, Resin

Cleared on May 19, 2000 after a 60-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: May 19, 2000
Review: 60 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK000894 C&B Resin Plus Powder/Liquid, Models Retemp A2, A3, A3.5, CL, Retemp…Dental Ventures of America, Inc. · 2000
Descendant · cites it directly · 0 of its ownK103474 Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for…Micerium S.P.A. · 2011

Most influential descendants

Showing 1 of 1 · See all

K103474Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)Micerium S.P.A. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000894	C&B Resin Plus Powder/Liquid, Models Retemp A2, A3, A3.5, CL, Retemp B2, B3…	Dental Ventures of America, Inc.	2000	—
+1	K103474	Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same…	Micerium S.P.A.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K000894, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K103474	Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)	Micerium S.P.A.	2011	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?

Of its descendants, K103474 (Micerium S.P.A., 2011) has gone furthest, with 0 descendants of its own.

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	—

https://510kreport.com/device/K000894 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000894: C&B Resin Plus Powder/Liquid, Models Retemp A2, A3, A3.5, CL, Retemp B2, B3, C2, D3, WH, Retemp MO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000894

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026