510(k) · Cleared

Cleared

3M Proplus System

K963766510(k) TraditionalCleared Oct 31, 199642-day reviewClass II21 CFR 872.3660

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

3M Company · ELW Material, Impression

Cleared on Oct 31, 1996 as substantially equivalent to K882690 (3M Company, 1988) and 3 other predicates after a 42-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.

Decided: Oct 31, 1996
Review: 42 days
Class: Class II
Product code: ELW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K863288 (1986). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK863288 Hydrophilic ReprosilDentsply Intl. · 1986
This deviceK963766 3M Proplus System3M Company · 1996
Descendant · cites it directly · 4 of its ownK120438 Flash (Different Materials)3M Deutschland GmbH · 2012
Descendant · 2 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
Descendant · 2 generations on · 0 of its ownK140602 Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014
Descendant · 3 generations on · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
Descendant · 3 generations on · 0 of its ownK133400 Flash Bite3M Espe AG · 2014

Most influential descendants

Showing 5 of 5 · See all

K120438Flash (Different Materials)3M Deutschland GmbH · 2012 · cites it directly4descendants
K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 2 generations on2descendants
K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014 · 2 generations on0descendants
K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 3 generations on0descendants
K133400Flash Bite3M Espe AG · 2014 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863288	Hydrophilic Reprosil	Dentsply Intl.	1986	—
0 (this device)	K963766	3M Proplus System	3M Company	1996	—
+1	K120438	Flash (Different Materials)	3M Deutschland GmbH	2012	—
+2	K131404	Flash AR Penta / Flash AR Penta Quick	3M Deutschland GmbH	2013	—
+2	K140602	Flash Penta MB Quick, Flash MB Quick	3M Espe AG	2014	—
+3	K133436	Flash AR; Flash AR Quick	3M Deutschland GmbH	2014	—
+3	K133400	Flash Bite	3M Espe AG	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	2	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	3	0

FIG. 1 — Lineage of K963766, 1986–2014Source: 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 ELW? 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 ELW device

#1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 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? (4)

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
*	K882690	Imprint Vinyl Polysiloxane Impression Material Summary page 1 …ession material Classification Name: Impression material (21 CFR 872.3660) Predicate devices: 3M™ Imprint™ Vinyl Polysiloxane Impression Material Single Phase System (K882690) Caulk®/Dentsply® Reprosil® Cartridge System (K863287) Kerr® Extrude™ Polyvinylsiloxane Impression Material System (K940379) E…	3M Company	1988	—
*	K863288	Hydrophilic Reprosil Our OCR of the scanned summary read K863287, FDA’s number for Uric Acid (Uricase) Method-II (Catachem, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Caulk®/Dentsply® Reprosil® Cartridge System”.	Dentsply Intl.	1986	—
*	K940379	Extrude Summary page 1 …ne Impression Material Single Phase System (K882690) Caulk®/Dentsply® Reprosil® Cartridge System (K863287) Kerr® Extrude™ Polyvinylsiloxane Impression Material System (K940379) Examix™ Hydrophilic Vinyl Polysiloxane Impression Material (K880849) 3M™ ProPlus System is composed of three hydrophilic vinyl…	Sybron Dental Specialties, Inc.	1994	—
*	K880849	Examix Dispenser Summary page 1 …Reprosil® Cartridge System (K863287) Kerr® Extrude™ Polyvinylsiloxane Impression Material System (K940379) Examix™ Hydrophilic Vinyl Polysiloxane Impression Material (K880849) 3M™ ProPlus System is composed of three hydrophilic vinyl polysiloxane dental impression materials. The system includes a tray…	G-C Intl. Corp.	1988	—

Also cleared against K882690: 3 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K120438	Flash (Different Materials)	3M Deutschland GmbH	2012	4

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?

None of the 4 ancestors has a recall.
Of its descendants, K120438 (3M Deutschland GmbH, 2012) has gone furthest, with 4 descendants of its own.
3 other devices also cite its predicate K882690.

How does its category compare?

All ELW devices

ELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELW

2in 2025

2007high 11 (2008) · low 2 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELW

98in 2024

2007high 268 (2026) · low 30 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ELW

3in 2016

2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ELW

22in 2025

2007high 35 (2014) · low 3 (2024)2025

MAUDE reports naming product code ELW, 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	7	60	0	9
2008	11	30	0	17
2009	7	43	0	7
2010	5	88	1	16
2011	9	83	0	15
2012	7	87	1	14
2013	5	67	3	32
2014	11	122	0	35
2015	8	93	0	18
2016	7	166	3	15
2017	3	89	0	17
2018	5	126	0	14
2019	2	—	0	24
2020	4	99	0	8
2021	3	76	0	6
2022	7	60	0	9
2023	2	—	0	13
2024	3	98	0	3
2025	2	—	0	22
2026	3	268	0	—

What is it indicated for?

3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963766: 3M Proplus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963766

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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