510(k) · Cleared

Cleared

Pro-V Coat

K103514510(k) TraditionalCleared May 25, 2011176-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

Bisco, Inc. · EBG Crown And Bridge, Temporary, Resin

Cleared on May 25, 2011 as substantially equivalent to K073263 (Bisco, Inc., 2008) after a 176-day review. Its family tree reaches back 2 generations to 1993.

Decided: May 25, 2011
Review: 176 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924132 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK924132 E.Z. Temep, Temporary Filling MaterialCosmedent, Inc. · 1993
1 generation backK073263 PRO-VBisco, Inc. · 2008
This deviceK103514 Pro-V CoatBisco, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924132	E.Z. Temep, Temporary Filling Material	Cosmedent, Inc.	1993	—
−1	K073263	PRO-V	Bisco, Inc.	2008	—
0 (this device)	K103514	Pro-V Coat	Bisco, Inc.	2011	—

FIG. 1 — Lineage of K103514, 1993–2011Source: 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

Get a 510(k) Report

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
*	K073263	PRO-V Summary page 1 …e Resin Class 11 per 21 CER 872.3770 Predicate Device: Pro-V Coat is substantially equivalent to Pro-V by Disco, Inc. Schaumburg IL K073263 Indications for Use: Pro-V Coat is indicated for use as a separating agent when placed between any resin based material and to…	Bisco, Inc.	2008	—

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 18 years and passes through 2 companies; a new generation was cleared every 14.6 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. 2011, 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?

Pro-V Coat is indicated for use as a separating agent when placed between any resin based material and to the substrate to which permanent bonding is not desired, such as:

1. any resin based material to the adhesive layer.

2. any resin based material to the remaining tooth structure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103514 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103514: Pro-V Coat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103514

Report an extraction error

Are you the manufacturer?

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