510(k) · Cleared

Cleared

Luxaform Plus

K033227510(k) TraditionalCleared Jan 16, 2004102-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

Dmg USA, Inc. · EBG Crown And Bridge, Temporary, Resin

Cleared on Jan 16, 2004 as substantially equivalent to K000951 (Dmg USA, Inc., 2000) and 2 other predicates after a 102-day review. Its family tree reaches back 1 generation to 1990.

Decided: Jan 16, 2004
Review: 102 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K900389 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK900389 Temporary Crown Matrix ButtonsAdvantage Dental Products, Inc. · 1990
This deviceK033227 Luxaform PlusDmg USA, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900389	Temporary Crown Matrix Buttons	Advantage Dental Products, Inc.	1990	—
0 (this device)	K033227	Luxaform Plus	Dmg USA, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2000	1	0

FIG. 1 — Lineage of K033227, 1990–2004Source: 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? (3)

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
*	K000951	Luxaform Summary page 1 …The proposed LuxaFormn Plus is substantially equivalent to the currently marketed DMG USA LuxaFormn material, which was cleared for marketing by FDA in K000951. In addition, the chemical composition of the LuxaFormn Plus material includes materials found in both the Advantage…	Dmg USA, Inc.	2000	—
*	K900389	Temporary Crown Matrix Buttons Summary page 1 …composition of the LuxaFormn Plus material includes materials found in both the Advantage Dental Products Temporary Crown Matrix Buttons as cleared in K900389 and the Heraeus Kulzer Paladur dental resin material, which was cleared in K915898. Product Description:…	Advantage Dental Products, Inc.	1990	—
*	K915898	Paladur Summary page 1 …Dental Products Temporary Crown Matrix Buttons as cleared in K900389 and the Heraeus Kulzer Paladur dental resin material, which was cleared in K915898. Product Description: The LuxaFormn Plus is a detailed quick pre-impression matrix used in the fabricat…	Heraeus Kulzer, Inc.	1992	—

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?

None of the 3 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.

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?

LuxaForm Plus is indicated for the following uses: * As a matrix in the fabrication of provisional dental crowns and bridges * Mini "custom tray" for impressions * Articulation of diagnostic molds * Articulation of the working cast against the opposing arch · For fabrication of a maxillary bite guard, a maxillary anterior or posterior bite plate or a maxillary anterior repositioning appliance * Direct fabrication of Maxillary sports guard in the mouth…

Read the full statement (126 words)

LuxaForm Plus is indicated for the following uses:

* As a matrix in the fabrication of provisional dental crowns and bridges

* Mini "custom tray" for impressions

* Articulation of diagnostic molds

* Articulation of the working cast against the opposing arch

· For fabrication of a maxillary bite guard, a maxillary anterior or posterior

bite plate or a maxillary anterior repositioning appliance

* Direct fabrication of Maxillary sports guard in the mouth without models

* Bite registration material either to be used directly or in combination with

three way trays (e.g. Triple Trays from Premier)

· Reinforcement of three way trays

· For use in functional therapeutic cases as e.g. a Lucia Jig, anterior

repositioning splint etc.

· Guiding matrix to help recreate anatomic form

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033227 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033227: Luxaform Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033227

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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